Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

This post was written by Paul Sheives.

FDA and the National Institutes of Health (NIH) have announced a new initiative aimed at improving efficiencies in translational science and regulatory science to close the gap in time between discovery of new technology and availability of therapies to patients. A new entity established under the initiative, the Joint Leadership Council, will seek to increase the consideration of regulatory issues early in the development of new technologies and therapies. In addition, the agencies jointly will issue grants totaling almost $7 million to develop better approaches to evaluating safety and efficacy for the development of new technologies and therapies. Additional information is available here. 

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This post was written by Paul Sheives.

On February 18, 2010, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System. The postings, which are mandated by the Food and Drug Administration Amendments Act of 2007, reflect safety information through September 2009. The FDA cautions that the appearance of a drug on this list does not mean that FDA has concluded that the drug has or causes the listed risk, nor does it suggest that healthcare providers should not prescribe or patients should not take the drug. If the FDA determines after further evaluation that the drug is associated with the risk, FDA could require labeling changes, require development of a Risk Evaluation and Mitigation Strategy (REMS), or gather additional data to better characterize the risk.

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This post was written by Paul Sheives.

A draft guidance was issued by FDA to help institutional review boards (IRBs) fulfill their continuing review responsibility under FDA regulations by providing guidance on the criteria, process, and frequency ofcontinuing IRB review necessary to ensure that subjects in clinical trials are protected.  Although directed primarily at IRBs, the draft guidance should also assist sponsors and clinical investigators to fulfill their responsibilities related to continuing review. The FDA is seeking comments on the draft guidance by March 15, 2010 for consideration when drafting the final guidance.

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This post was written by Paul Sheives.

FDA published a guidance document aimed at sponsors that are developing drug products with the potential for abuse that may need to be scheduled by the Drug Enforcement Agency (DEA) under the Controlled Substances Act.    Within the draft guidance document, FDA addresses both the definition of abuse potential and information on submitting an adequate abuse potential assessment and scheduling request – covering such topics as study design and administrative recommendations.  Comments should be submitted by March 29, 2010 to be considered when the FDA drafts its final guidance. 

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This post was written by Paul Sheives.

In an effort to better streamline medical device clinical trials, FDA issued a guidance document that addresses the use of Bayesian methods in medical device clinical trials. FDA provides a general overview of Bayesian methods and discusses how they intersect with the design and analysis of medical device clinical trials. The advantages and challenges inherent when using Bayesian methods are discussed, and FDA offers some comparisons to more standard statistical methods. In particular, FDA notes that this methodology allows companies to combine data collected in previous studies with data collected in a current trial, and the combined data may provide sufficient justification for smaller or shorter clinical studies. The use of Bayesian methods in post-market studies is explored as well.

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This post was written by Paul Sheives.

FDA recently issued a revision of an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document, M3(R2), that was published in 1997 and is intended to harmonize and recommend international standards for non-clinical safety studies conducted to support human clinical trials of a given scope and duration, and/or to be relied upon for marketing authorization for pharmaceuticals. In this revised guidance document, FDA includes a new discussion relating to exploratory clinical studies. Also included are recommendations to help sponsors determine when certain nonclinical studies should be performed, such as phototoxicity studies, immunotoxicity studies, juvenile animal toxicity studies, and abuse potential studies.

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This post was written by Paul Sheives.

To maximize the agency’s efforts to process submissions for the evaluation of proprietary names within the deadlines under the Prescription Drug User Fee Act (PDUFA), FDA issued a guidance document to assist manufacturers in making a complete submission, which is required for the PDUFA review clock to begin. FDA discusses the collection of information that the agency requires to assess: (1) the safety aspects of a proposed proprietary name in order to reduce medication errors, and (2) the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using traditional FDA review methods.

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This post was written by Paul Sheives.

FDA recently announced an initiative seeking to minimize patient exposure to ionizing radiation associated with computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams. To further this goal, the agency is advocating the universal adoption of two principles of radiation protection: (1) appropriate justification for ordering each procedure, and (2) careful optimization of the radiation dose used during each procedure. FDA states that “each patient should get the right imaging exam, at the right time, with the right radiation dose.” The FDA released a white paper on the initiative along with a question and answer document. 

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This post was written by Paul Sheives.

The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities. Medically-necessary products are those used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute.  

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The FDA has released final guidance for industry entitled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The document describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments (i.e., a questionnaire plus supporting information and documentation) used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling.

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This post was written by Paul Sheives.

The Food and Drug Administration (FDA) has announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. The program is summarized in an FDA report entitled “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines.” The report outlines FDA’s intention to identify safety issues linked to preventable harm via collaboration with health care professionals and other stakeholders. The report also provides examples of several risk-reduction areas in which Safe Use collaborations may prove useful, including evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.  

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This post was written by Paul Sheives.

The FDA recently held a hearing to help the agency determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the internet and newer technologies. Although the hearing was only an information gathering exercise for FDA, FDA acknowledged the industry’s concern that the Internet is a different medium with unique concerns that must be addressed. 

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This post was written by Paul Sheives.

On November 19, 2009, FDA completed a coordinated and collaborative international effort intended to curb illegal actions involving medical products sold via the internet. The agency issued 22 warning letters to the operators of these web sites and notified internet service providers and domain name registrars that the web sites were selling products in violation of U.S. law. FDA noted that, in many cases, because of these violations, internet service providers and domain name registrars may have grounds to terminate the websites and suspend the use of domain names. 

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This post was written by Paul Sheives.

FDA released a number of final and draft guidance documents in November, including the following:

• Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins;
• Draft Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods;
• Draft Guidance for Industry on Dosage Delivery Devices for Over-the-Counter Liquid Drug Products;
• International Conference on Harmonisation; Draft Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers;
• Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; and
• Several final and draft guidance documents on tobacco products, including guidance on listing of tobacco ingredients, applications for modified risk tobacco products, and registration of owners and operators of tobacco product establishments.

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This post was written by Paul Sheives.

FDA has completed the “New Molecular Entity Postmarketing Safety Evaluation Pilot Program” that began in January, 2007. This pilot program undertook a systematic and collaborative review of the safety profiles of selected approved new molecular entities that have been marketed for varying lengths of time.  The pilot program determined the value of such a systematic review, noting the substantial effort and personnel resources involved.

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This post was written by Paul Sheives.

FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement discretion regarding IND and Biologics License Application (BLA) requirements for these products. The final guidance document is entitled “Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,” and the draft guidance is entitled “Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications.” Other recent FDA guidance documents include the following:

• Labeling for Human Prescription Drug and Biological Products--Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.
• Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.
• Guidance for Industry on Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects.

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The FDA has issued its “Strategic Plan for Risk Communication,” which outlines how the agency intends to communicate information about the risks and benefits of FDA-regulated products with various public audiences, including health professionals, patients, and consumers. The plan includes more than 70 actions the FDA plans to take over the next five years to: strengthen the science that supports effective risk communication; expand FDA’s capacity to generate, disseminate, and oversee effective risk communication; and optimize FDA policies on communicating risks and benefits.

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The FDA has issued a final guidance document for industry on “Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.” The FDA also is soliciting comments on a number of draft guidance documents, including the following:

• Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications; to be considered by the agency in developing the final guidance, comments should be submitted by December 30, 2009.
• The Scope of the Prohibition Against Marketing a Tobacco Product in Combination With Another Article or Product Regulated Under the Federal Food, Drug, and Cosmetic Act;  comments are due January 4, 2010.
• Mammography Quality Standards Act Final Regulations; comments will be accepted until January 7, 2010.

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On August 7, 2009, the FDA announced its enhanced procedures for debarment and clinical investigator disqualification with, among other things, increased staffing and centralized coordination, to ensure more rapid, transparent and consistent actions. The FDA notes that in the short time these measures have been in effect, the number of debarment actions has risen considerably while the times for resolving disqualification and debarment actions have been reduced significantly. The FDA also is posting disqualification and debarment proceeding information on its website to provide clinical study sponsors with ready access to information about FDA's actions. These policy changes are in response to concerns expressed by members of Congress that the FDA has not adequately used its debarment and disqualification authorities.

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On August 3, 2009, the FDA published a number of notices setting forth the fiscal year 2010 user fee rates for prescription drugs, medical devices, animal drugs, and generic animal drugs.

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The FDA has published a notice announcing the availability of a draft guidance entitled “E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.” The FDA is requesting comments on the guidance by September 28, 2009.

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The FDA is accepting comments on the following new draft guidance documents for industry:

• Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting; to be considered in drafting the final guidance, comments must be received by October 13, 2009.  
• Postmarketing Studies and Clinical Trials— Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act; comments are due October 13, 2009.

In addition, the FDA recently has issued a number of final guidance documents and “frequently asked question” documents, including the following:

• Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.
• Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. 
• Frequently Asked Questions: Institutional Review Board Registration.
• Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances (Revision 1).

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On June 2, 2009, the Food and Drug Administration (FDA) announced the formation of a task force to develop recommendations for enhancing the transparency of the FDA’s operations and decision-making process. The task force, which will be chaired by Principal Deputy Commissioner Joshua Sharfstein, M.D., will:

• Seek public input on issues related to transparency;
• Recommend ways that the agency can better explain its operations compatible with the appropriate protection of confidential information;
• Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals;
• Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision-making to the public;
• Identify appropriate tools and new technologies for informing the public;
• Recommend changes to the FDA’s current operations, including internal policies and guidance, to improve the agency’s ability to provide information to the public in a timely and effective manner;
• Recommend legislative or regulatory changes, if appropriate, to improve the FDA’s ability to provide information to the public; and
• Submit a written report to the commissioner on the Transparency Task Force’s findings and recommendations.

To further these efforts, the FDA is holding a meeting June 24, 2009 to solicit recommendations on how the agency can improve the way it provides information about FDA activities to the public.

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The FDA has issued final guidance on “Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing.'' As of June 1, 2009, FDA will only accept electronic submissions of drug establishment registration and drug listing information, unless a waiver is granted. This document provides guidance to manufacturers, repackers, and relabelers on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive.

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The FDA is seeking comments on a draft guidance document entitled “The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application.” This draft guidance provides information to those using radioactive drugs for certain research purposes to help determine whether research studies may be conducted under an FDA-approved radioactive drug research committee, or whether research studies must be conducted under an investigational new drug application. It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA. Comments received on the draft by September 1, 2009 will be considered by FDA when drafting the final guidance.

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On June 8, the FDA announced the availability of final product-specific BE recommendations, which provide product-specific guidance on the design of BE studies to support abbreviated new drug applications. The FDA also published a separate document proposing additional draft and revised draft product-specific BE recommendations; comments on the draft recommendations will be accepted until September 8, 2009.

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The FDA has released guidance on “Medication Guides: Adding a Toll-Free Number for Reporting Adverse Events.” Beginning July 1, 2009, manufacturers of prescription drug products approved under the Federal Food, Drug, and Cosmetic Act that are required to have a Medication Guide must add a verbatim statement to their Medication Guides containing FDA's toll-free number for reporting side effects. These manufacturers also must report to FDA that they have complied with this requirement. This guidance explains what statement to add to Medication Guides, where to add it, and how to notify the agency that such a statement has been added. 

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The FDA has issued final guidance regarding formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research (note that the guidance does not apply to abbreviated new drug applications). Specifically, the guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting formal meetings. The document supersedes the guidance entitled “Formal Meetings With Sponsors and Applicants for PDUFA Products” published in February 2000. 

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The FDA has released a compliance guidance entitled “Labeling OTC Human Drug Products; Small Entity Compliance Guide.” The document, which finalizes draft guidance published in December 2004, is intended to help small businesses better understand and comply with the agency's over- the-counter (OTC) labeling requirements and to prepare new labeling.

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The FDA has issued draft guidance on “Label Comprehension Studies for Nonprescription Drug Products.” The draft guidance provides recommendations on the design of label comprehension studies, which can be used to assess the extent to which consumers understand information conveyed by proposed nonprescription drug product labeling and then apply that information when making hypothetical drug use decisions. Comments on the draft are due July 30, 2009.

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The FDA has released a draft guidance document providing technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The agency is accepting comments on the draft through July 27, 2009. 

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On June 1 and 2, 2009, the FDA is holding a public workshop on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices. Issues to be discussed may include: multi-scale modeling; imaging for cardiovascular device modeling; physiologic input data for cardiovascular device modeling; device-specific issues related to modeling, including a focus on heart valves, drug-eluting and bare metal stents, endovascular stents, cardiac rhythm management, and mechanical and circulatory support devices; and regulatory issues with implementation of computer modeling.

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The Food and Drug Administration (FDA) has released draft guidance for industry entitled “Submission of Summary Bioequivalence Data for ANDAs.” The draft guidance is intended to assist ANDA applicants in complying with new requirements in a January 2009 final rule that requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval. The guidance is applicable to BE studies conducted during both preapproval and postapproval periods. FDA is accepting comments on the draft guidance until July 16, 2009.  

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The FDA is announcing the availability of final guidance for industry entitled “Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.” The guidance clarifies where within the new drug application (NDA) and biologics license application (BLA) common technical document (CTD) format to include an integrated summary of effectiveness (ISE) and integrated summary of safety (ISS), and it addresses other related FDA requirements.

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The FDA has issued an order requiring manufacturers of remaining preamendments class III devices for which regulations requiring submission of premarket approval applications (PMAs) have not been issued to submit to FDA certain safety and effectiveness information. Specifically, these manufacturers must submit a summary of, and a citation to, any available information respecting such devices, including adverse safety or effectiveness information, which has not been submitted under the Federal Food, Drug, and Cosmetic Act. The FDA is requiring the submission of this information to determine whether the classification of each device should be revised to require the submission of a PMA or a notice of completion of a Product Development Protocol, or whether the device should be reclassified into class I or II. The deadline for information submission is August 7, 2009.  

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On May 1, 2009, the FDA is holding a public meeting regarding economically motivated adulteration (EMA), which FDA defines as the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production (i.e., for economic gain). EMA includes dilution of products with increased quantities of an already-present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product) to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution. Several recent incidents involving FDA-regulated products (heparin, glycerin, infant formula, and pet food), are suspected to be examples of EMA. The purpose of the meeting is to stimulate discussion about ways in which the food (including dietary supplements and animal food), drug, medical device, and cosmetic industries, regulatory agencies, and other parties can better predict and prevent EMA, with a focus on situations that pose the greatest public health risk. The agency also invites written comments on this issue; the comment deadline is August 1, 2009.

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On April 1, 2009, the FDA issued a final rule amending its regulations to reflect FDA organizational changes and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations. The rule is effective April 1, 2009.

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The FDA is seeking comments on a draft document entitled “Guidance for Industry: Somatic Cell Therapy for Cardiac Disease,” which provides sponsors of cellular therapies for the treatment of cardiac disease with recommendations on the design of preclinical and clinical studies, and information that should be submitted about the product delivery system. It also provides recommendations on the chemistry, manufacturing, and controls information to include in an investigational new drug application for cardiac cellular therapy. Comments will be accepted until July 1, 2009.   

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The FDA is seeking comments on a draft guidance document entitled “User Fees and Refunds for Premarket Approval Applications'' (PMAs). The draft document outlines the types of PMAs subject to user fees, as well as those that do not have an associated user fee, and identifies industry and FDA actions on these submissions that may result in a refund of the fee. Comments on the draft guidance will be accepted through April 15, 2009. The FDA also has released “Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files,” which is designed to simplify the preparation and evaluation of submissions in support of new animal drug applications. Comments will be accepted until June 1, 2009.

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On March 14, 2009, President Obama named Dr. Margaret Hamburg as Commissioner of the Food and Drug Administration, and Dr. Joshua Sharfstein as the Principal Deputy Commissioner.  The following profiles were supplied by the White House:

Margaret "Peggy" Hamburg
Dr. Hamburg is a nationally and internationally recognized leader in public health and medicine, and an authority on global health, public health systems, infectious disease, bioterrorism and emergency preparedness. She served as the Nuclear Threat Initiative's founding Vice President for the Biological Program. Before joining NTI, she was the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Prior to this, she served for six years as the Commissioner of Health for the City of New York and as the Assistant Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Joshua "Josh" Sharfstein
Dr. Joshua M. Sharfstein is Commissioner of Health for the City of Baltimore. He also serves as chair of the board of four affiliated nonprofit agencies. He has been recognized as a national leader for his efforts to protect children from unsafe jewelry and over-the-counter medication, and ensuring Americans with disabilities have access to prescription drugs. He is a member of the Board on Population Health and Public Health Practice of the Institute of Medicine.
 

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The FDA is soliciting comments on the following draft guidance documents:

• “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format'' -- comments will be accepted until June 1, 2009.
• “Process Validation: General Principles and Practices” – the comment period has been reopened until March 16, 2009.
• The FDA has issued several draft guidance documents prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first draft document addresses Nonclinical Evaluation for Anticancer Pharmaceuticals. Three draft documents address Evaluation and Recommendation of Pharmacopoeial Texts, covering chapters on Uniformity of Dosage Units, Dissolution Test, and Sterility Tests. The comment deadline for each of these guidance documents is April 20, 2009. 

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The FDA has announced the availability of the source code and supporting technical documentation for the Phonetic Orthographic Computer Analysis (POCA) software program. POCA is an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically similar to one another, which FDA uses to review proposed proprietary drug and biologic names. 

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On February 4, 2009, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System. The postings, which are mandated by the Food and Drug Administration Amendments Act of 2007, reflect safety information through September 2008. The FDA cautions that the appearance of a drug on this list does not mean that FDA has concluded that the drug has or causes the listed risk, nor does it suggest that healthcare providers should not prescribe or patients should not take the drug. If the FDA determines after further evaluation that the drug is associated with the risk, FDA could require labeling changes, require development of a Risk Evaluation and Mitigation Strategy (REMS), or gather additional data to better characterize the risk.  

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On January 13, 2009, the FDA announced on behalf of the Interagency Working Group on Import Safety the availability of draft guidance on “Good Importer Practices.”  The draft guidance document provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood the products they import (including drugs) comply with applicable U.S. safety and security requirements. Comments will be accepted through April 13, 2009. 

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The FDA has released a draft document entitled “Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The draft document provides establishments that manufacture HCT/Ps with recommendations for complying with CGTP requirements. This guidance also addresses whether the establishment registration and HCT/P listing requirements under 21 CFR part 1271, subparts A and B apply in certain instances. The FDA will accept comments on the guidance through April 16, 2009. 

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The FDA has released draft guidance on “Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” which recommends standards industry should use for the identification of individual packages containing prescription drugs under the FDAAA. The standards are designed to facilitate adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. The FDA is soliciting comments on certain aspects of the guidance, as detailed in a January 16, 2009 notice. Comments will be accepted until April 16, 2009.

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The FDA has released final guidance on “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007.” The guidance describes the FDA’s current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications under the FDAAA related to the submission of required information to the clinical trials data bank, www.ClinicalTrials.gov.

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On January 16, 2009, the FDA published a notice announcing “Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories,” which is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA's requirements. The guidance advises importers how to use accredited laboratories and makes recommendations about the quality and type of test data that these laboratories should produce to support test results submitted to the FDA. According to an FDA press release, the guidance also is intended to reduce the likelihood that an importer will submit only favorable test results to the FDA. Comments on the draft will be accepted through April 16, 2009.  

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The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the public reporting requirements for “applicable clinical trials” involving certain drugs, biologicals, and devices. In December 2008, the Food and Drug Administration (FDA) issued a draft guidance document proposing, among other things, definitions that would affect who would be required to register certain clinical trials under the FDAAA. In some cases, FDA's proposal would require manufacturers who make grants to investigators to be the responsible party required to register. In addition, FDA elaborates on the circumstances under which clinical investigations designed to demonstrate bioequivalency would be subject to reporting. Additional background information is available at the clinicaltrials.gov web site. Reed Smith is reviewing the draft guidance. Please contact Areta Kupchyk at akupchyk@reedsmith.com for more information.

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The FDA has released final guidance on “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act,” which discusses the amount, type, and quality of evidence that FDA recommends a dietary supplement manufacturer have to substantiate a nutritional deficiency, structure/function, or general well-being claim. FDA has adopted the FTC standard for substantiation and, among other things, will expect statistically significant clinical studies to support structure/function claims. For more information, contact Areta Kupchyk at akupchyk@reedsmith.com.

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The FDA has issued final guidance on “Labeling OTC Human Drug Products—Questions and Answers.” This document is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products in complying with the agency’s regulation on standardized content and format requirements for the labeling of OTC drug products, including the use of toll-free numbers and compliance with adverse event reporting requirements.

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The FDA has released draft guidance entitled “Assay Migration Studies for In Vitro Diagnostic Devices,” which is designed to present a least burdensome regulatory approach to gaining FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously-approved assay is migrating to a new system for which the assay has not been previously approved or licensed. FDA will accept comments on the draft guidance until April 6, 2009. 

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The FDA is inviting pharmaceutical companies to participate in the FDA’s Regulatory Project Management Site Tours and Regulatory Interaction Program, through which FDA personnel observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/toxicology laboratories, and regulatory affairs operations. The goals of the program are to provide FDA regulatory project managers with first-hand exposure to industry’s drug development processes, and to offer a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives.  Interested companies may submit proposed agendas to FDA by March 6, 2009. 

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FDA is soliciting comments on the paperwork burden associated with its plan to require drug establishment registration and drug listing submissions in electronic format. Comments will be accepted until February 9, 2009. 

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The FDA has released revised draft guidance entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.” This guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. In an earlier version of the guidance issued January 2, 2008, the FDA stated that it intended to begin enforcing the labeling requirements for OTC drug products marketed without an approved application that are labeled on or after January 1, 2009; because the agency is still finalizing the guidance, the revised draft extends the enforcement date until January 1, 2010. Separate guidance regarding compliance with the labeling requirements for dietary supplements also has been released.

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The FDA has released draft guidance on “Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.” The document reflects the agency's views on genotoxic and carcinogenic impurities in drug substances and drug products, including biologic products regulated by the Center for Drug Evaluation and Research. It also provides recommendations on how to evaluate the safety of these impurities during clinical development and for marketing applications, including additional testing and exposure threshold recommendations when genotoxic or carcinogenic impurities are present. The draft guidance addresses synthetic impurities and degradants in drug substances, but not the genotoxicity or carcinogenicity of actual drug substances or intended drug product ingredients. This draft guidance also applies to known starting materials or anticipated reaction products. The FDA will accept comments on the guidance through February 17, 2009. 

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The FDA has issued guidance on “Modifications to Devices Subject to Premarket Approval (PMA)--the PMA Supplement Decision-Making Process,” which is designed to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified.  

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The FDA has released guidance for manufacturers of new and generic pharmaceutical products on the definition of an orally disintegrating tablet (ODT). The FDA notes that manufacturers have developed products that can be ingested simply by placing them on the tongue, eliminating the need to chew the tablet, swallow an intact tablet, or take the tablet with liquids. As new products have been developed using different technology and formulations, many of these later products exhibited wide variation in product characteristics from the initial products. Because this shift in product characteristics can affect suitability for particular uses, the agency developed this guidance for industry.

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The FDA has released for public comment draft guidance entitled “Submission of Patent Information for Certain Old Antibiotics.” The document describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications must submit patent information under the Q1 Act by December 5, 2008. Comments on the guidance will be accepted until February 2, 2009. 

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The FDA has announced the availability of a document entitled “Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.” The guidance, which applies to biological products subject to licensure under the U.S. Public Health Service Act, describes the licensing strategies for meeting the increased need for flexible manufacturing arrangements, such as short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements.

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On December 3, 2008, the FDA announced it is teaming with WebMD to expand consumer access to FDA safety alerts and other public health information. Among other things, the partnership includes a new online consumer health information resource on WebMD.com where consumers can access information on the safety of FDA-regulated products. 

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HHS announced it is preparing to open FDA offices in China, India, Europe, and Latin America before the end of 2008 to beef up efforts to ensure the safety of imported food and medical products. FDA personnel overseas will be tasked with providing technical advice to local authorities and industries, conducting additional inspections, and working with government agencies and private sector entities interested in developing certification programs. This initiative is part of the federal government’s Import Safety Action Plan. 

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The Food and Drug Administration (FDA) has released a draft guidance document on “Potency Tests for Cellular and Gene Therapy Products.” The document is designed to provide manufacturers of cellular and gene therapy products with recommendations for developing tests to measure potency to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). FDA will accept comments on the guidance through January 7, 2009. 

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The FDA released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.   Among other things, the guidance requires producers to demonstrate that food from the GE animal is safe to eat if the GE animal is intended for food use. The guidance also describes a sponsor's responsibility in meeting the National Environmental Policy Act’s environmental assessment requirement.   The draft guidance also describes how the FDA may exercise enforcement discretion with regard to GE animals. The FDA will accept comments on the guidance through November 18. 

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On September 5, 2008, the FDA posted its first quarterly report listing 20 specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System, as mandated by the Food and Drug Administration Amendments Act of 2007. The FDA cautions that the appearance of a drug on this list does not mean that FDA has concluded that the drug has or causes the listed risk, nor does it suggest that healthcare providers should not prescribe or patients should not take the drug. If the FDA determines after further evaluation that the drug is associated with the risk, FDA could require labeling changes, require development of a Risk Evaluation and Mitigation Strategy (REMS), or gather additional data to better characterize the risk. 

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The FDA has released its “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan,” which describes the FDA’s vision for improving the automation of business processes and maintaining information systems that support the review process of human drug applications. Comments on the plan may be submitted at any time. Details are available here.

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On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System” -- a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. According to the FDA, the Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort. A Reed Smith bulletin discussing this initiative in greater detail is posted here.

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