FDA Public Meeting on Regulatory Oversight of Laboratory Developed Tests (Jan 8-9)

The FDA has scheduled a public workshop on the “Framework for Regulatory Oversight of Laboratory Developed Tests'' on January 8 – 9, 2015. The purpose of the workshop is to discuss FDA's proposal for a risk-based framework for addressing the regulatory oversight of “laboratory developed tests,” a subset of vitro diagnostic devices intended for clinical use and designed, manufactured and used within a single laboratory. Among other things, the FDA will address LDT labeling considerations; clinical validity and intended use; enforcement discretion; adverse event reporting; quality system regulation; and procedural issues. The workshop registration deadline is December 12, 2014. FDA will accept comments related to the public workshop until February 2, 2015.

FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

This post was written by Jennifer Pike and Vicki Morris.

Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page "Informed Consent Information Sheet" that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will supersede FDA’s previous Information Sheet on this topic, "A Guide to Informed Consent," which was last updated over 15 years ago, in 1998.  The guidance, which is a compilation of FDA’s regulations and past guidances on informed consent, also reflects the Agency’s coordinated efforts with the Department of Health and Human Services (HHS) to facilitate consistency across informed consent requirements and policies among federal government agencies.

Broadly, the new guidance indicates FDA policy shifting towards enhanced informed consent processes. More narrowly, the draft guidance explains the various and often caveated elements of informed consent (including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality and compensation in the event of injury), depicts the detailed responsibilities of IRBs, clinical investigators and sponsors of clinical trials (including compliance with the process, elements and documentation of informed consent), and provides examples of recommended language to assist industry parties in complying with FDA’s informed consent regulations. FDA accomplishes this task by clarifying some aspects of existing guidance and creating additional guidance in new areas.

The following provides an overview of some of the draft guidance’s notable new and revised provisions.

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Hundreds of Drugs and Biologics Face Labeling Changes under New FDA Plan

This post was written by Jennifer Pike.

In a notice published in the Federal Register on May 7, 2014, the U.S. Food and Drug Administration (“FDA”) announced its intent to incentivize manufacturers to voluntarily update their prescription drug and biologics labels by using a government contractor.

FDA’s announcement stems from a January 2006 final rule in which FDA established revised content and format requirements for prescription drugs and biologics (the “Physician Labeling Rule” or “PLR”). The PLR required drugs and biologics approved after June 30, 2001 to adopt the new labels. A detailed implementation schedule under the PLR, which only resulted in only 15% of all drug and biologics being labeled in the PLR format, expired in November 2013. Therefore, moving forward, the only products which will be labeled in the PLR format will be new drugs and biologics and drugs that are voluntarily updated. To address this lack of labeling conversion, on February 6, 2013, FDA proposed the Prescription Drug Labeling Improvement and Enhancement Initiative. As part of the initiative, and as explained in detail in FDA’s notice, FDA plans to use a government contractor to provide PLR conversion resources and services, including preparation of draft PLR format labeling, in hopes of facilitating voluntary conversion.

The number of drugs and biologics affected by FDA’s initiative is staggering. FDA estimates that 375 manufacturers will be contacted over a 5 year period regarding 750 products. FDA will select the products for labeling conversion based on criteria that would maximize the benefit to public health, including volume of prescriptions, clinical relevance, and risk-based  considerations. Beyond the 750 products selected for PLR conversion, FDA further estimates that over 1,800 generic products will require labeling updates to reflect changes made to the corresponding brand-name products.

FDA is seeking public comment on its collection of information related to the initiative. Comments should be submitted in writing, or electronically at www.regulations.gov, on or before July 7, 2014.

Busy Week for FDA's Center for Devices and Radiological Health

This post was written by Jillian W. Riley

Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product.

The first guidance, entitled Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval, clarifies FDA’s current thinking on creating an effective means to achieve “the right balance of premarket and postmarket data collection facilitates timely access to important new technology without undermining patient safety.” Greater reliance on postmarket data collection can help a new product reach the market – and patients – sooner. One key factor FDA considers when determining whether postmarket data collection is appropriate is the device’s potential impact on public health. For example, and as discussed more thoroughly in the separate guidance discussed below, FDA may accept greater pre-approval uncertainty regarding specific benefits and risks of devices where there is demonstrated potential to address unmet medical needs.

The second guidance, Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions, proposes a new expedited review program for medical devices that address unmet medical needs and are subject to premarket approval (PMA) applications. The program laid out in the draft guidance establishes opportunities for earlier and more active engagement between sponsors and FDA staff, including earlier involvement of senior management to ensure more consistency in messaging to industry. The early interactions aim to establish better plans for efficient collection of the scientific and clinical data necessary to support FDA’s approval determinations. The guidance also describes the criteria an applicant must meet in order to obtain an expedited access PMA designation.

FDA will be accepting comments regarding the draft guidances until July 23, 2014.

FDA Proposal Amends Medical Device Classification Rules

This post was written by Jennifer Pike.

On March 25, 2014, the Food and Drug Administration (FDA) published a proposal to amend its regulations governing the classification and reclassification of medical devices. In addition to conforming the regulations to recent changes made by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the proposed rule makes changes unrelated to FDASIA. Among other changes to 21 CFR Part 860, FDA proposes to:

  • Amend several definitions at 21 CFR § 860.3, including the definitions of Class I, Class II and Class III to reflect the key principle underlying device classification that a reasonable assurance of safety and effectiveness is necessary for all three classes, but that the level of regulation necessary to provide such assurance is specific to the level of risk.
  • Amend the definition of Class III to clarify which devices fall in this category.
  • Establish special controls for Class II devices by replacing the term “performance standards” in 21 CFR § 860.7.
  • Amend 21 CFR § 860.84 to remove from the classification process the requirement to answer the classification questionnaire and provide information using the supplemental data sheet.
  • Revise the procedure at 21 CFR § 860.130 to reflect the FDASIA requirement that devices reclassified under 513(e) of the Food, Drug and Cosmetic Act be reclassified using an administrative order procedure.
  • Revise the process under 21 CFR § 860.133 for the filing of a premarket approval for Class III preamendment devices to conform to FDASIA.

Comments to the proposed rule may be submitted in writing, or at www.regulations.gov, on or before June 23, 2014.

There are HOW many calories in that? FDA Seeks Comments on Proposal to Update Nutrition Facts Food Label

As mentioned on our Life Sciences Legal Update blog, the Food and Drug Administration (FDA) announced today it has proposed significant updates to the Nutrition Facts label for foods intended to expand and highlight the information consumers need to make well-informed food choices.  FDA also is proposing changes to how serving sizes themselves are calculated. FDA will be accepting comments on the proposed regulations for 90 days.  To read the entire post, click here.

FDA to Overhaul an OTC System That "Isn't Working"

This post was written by Kevin M. Madagan and Jillian W. Riley

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.

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Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

This post was written by Jennifer Pike.

In a notice published in the Federal Register on February 18, 2014, the Food and Drug Administration (FDA) asked for feedback on a proposed research study related to prescription drug television advertisements. The study, Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads), would investigate the impact of limiting the risks presented in DTC prescription drug TV ads to those that are serious and actionable. The ads would also include a disclosure statement to alert consumers that there are other product risks not included in the ad.

Current FDA regulations (21 CFR § 202.1) require that TV and radio ads present a product’s major risks in audio, or audio and visual parts of the ads (“major statements”). FDA is concerned that these major statements are too long, resulting in reduced consumer comprehension, minimization of important risk information, and potentially, therapeutic noncompliance due to fear of side effects. At the same time, and in conflict with the above, FDA is concerned that DTC TV ads do not include adequate risk information. FDA believes that providing limited risk information in ads will promote improved consumer perception and understanding of serious and actionable drug risks.  Comments to the study should be submitted in writing, or electronically at www.regulations.gov, by April 21, 2014.

FDA Seeks Comments on Drug Company Social Media Guidance

As reported on our Life Sciences Legal Update blog, the FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance addresses how to submit interactive promotional media for postmarket review.  Comments on the document, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” are due April 14, 2014.

CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

In October 2011, CMS and the FDA formally launched a voluntary parallel review pilot program for sponsors of medical devices. At the time, the agencies stated that they intended to run the pilot program for two years, with the possibility of an extension. In a December 18, 2013 notice, the FDA and CMS announced that they were extending the program for another two years in light of the significant interest in the pilot. The agencies are working through the process with the approved pilot program participants, and they will formally evaluate the program after a “representative group of participants have completed the pilot process.”

FDA Releases Final Guidance on Qualification Process for Drug Development Tools

This post was written by Jennifer Pike.

The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments.

The purpose of the guidance document is to describe the formal process that FDA will use in working with sponsors of DDTs to guide them as they refine the tools and rigorously evaluate them for use in the regulatory process. The guidance also provides a framework for interactions between FDA and sponsors to support work towards qualification of DDTs, as well as explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for FDA’s formal review of the data to ultimately qualify the DDT. For purposes of the guidance, the submitter of a DDT is the person, group, organization (including the federal government), or consortium that takes responsibility for and initiates a DDT qualification proposal using the procedures described in the guidance.

The creation of the DDT qualification process is one of multiple initiatives FDA has undertaken, as a result of its 2004 FDA’s Critical Path Initiative, to support the development of new DDTs. DDTs can help streamline the drug development process, improve the chances for clinical trial success, and yield more information about a treatment or disease. Comments to the guidance may be submitted at any time at www.regulations.gov.

FDA Proposes New Rule to Exercise its Administrative Detention Authority for Drugs

This post was written by Jennifer Pike.

On July 15, 2013, the Food and Drug Administration (FDA) published in the Federal Register a proposed rule that would amend 21 CFR Part 1 to implement FDA’s detention authority with respect to drugs intended for human or animal use. FDA’s detention authority is authorized by amendments made to the Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act. Once finalized, FDA would be able to detain drugs encountered during an inspection that are reasonably believed to be adulterated or misbranded. According to FDA, the authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate. Comments on the proposed rule should be submitted in writing, or electronically at www.regulations.gov, on or before September 13, 2013.

FDA Amends Orphan Drug Regulations

This post was written by Jennifer Pike.

On June 12, 2103 the Food and Drug Administration (FDA) published a final rule amending the orphan drug regulations (21 CFR Part 316). The amendments are intended to clarify regulatory provisions and make minor improvements to address issues regarding orphan drug designation and orphan drug exclusivity.

The final rule largely finalizes the amendments as proposed in October 2011. Reed Smith previously prepared a client alert summarizing the proposed rule and discussing the potential impact of the proposal on the drug, biological product, and biotechnology industries. In the final rule, the FDA has revised the proposed rule by, among other things:

  1. Adding a definition of "orphan subset" that is consistent with the explanation of orphan subset in the proposed rule;
  2. Clarifying the existing regulation in accordance with FDA’s long-standing practice that a designated drug is eligible for orphan exclusive approval only if the same drug has not already been approved for the same use or indication;
  3. Removing language stating that to demonstrate clinical superiority in terms of "major contribution to patient care," the drug must provide safety and effectiveness "comparable to the approved drug," because the language incorrectly implied that FDA would require direct proof of comparability (e.g., through non-inferiority trials);
  4. Updating the contact information required in requests for designation and for permanent-resident agents;
  5. Clarifying that a designation request need only include "relevant" in vitro laboratory data and data from "clinical experience" with the drug;
  6. Clarifying that FDA will notify the sponsor in writing whenever FDA considers a designation request voluntarily withdrawn;
  7. Codifying FDA’s longstanding interpretation that FDA can refuse to grant a designation request if the request is otherwise ineligible for designation under Part 316;
  8. Stating that that FDA’s publicly-available posting of designated drugs will include whether a drug is no longer designated if the drug loses designation after the effective date of the final rule;
  9. Making explicit an option that has always existed for sponsors – that sponsors may voluntarily withdraw a designation request, or an actual designation, at any time by submitting a written request to FDA; 
  10. Clarifying that the scope of orphan drug exclusivity is limited to the indications or uses for which the designated drug is approved;
  11. Clarifying that that a designated drug that is otherwise the same as a previously approved drug receives 7-years market exclusivity ("orphan drug exclusivity") upon approval only if the sponsor of the second-in-time drug demonstrates upon approval that its drug is clinically superior to the previously approved drug; and
  12. Updating the FDA address listed in the regulations and adding an online address for the Orange Book.

The final rule is effective on August 12, 2013.

FDA Issues New Guidance Documents

This post was written by Jennifer Pike.

In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following:

FDA Issues Final Rule on Current Good Manufacturing Practice Requirements for Combination Products

This post was written by Jennifer Pike.

FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule clarifies which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. For certain types of combination products the application of CGMP requirements is straightforward – the constituent parts of a combination product are each subject only to the CGMP requirements applicable to that type of constituent part if the parts are manufactured and marketed separately. In other words, where parts of a combination product are separately manufactured and marketed, they remain separate for the purposes of applying CGMP regulations. The application of CGMP requirements to “single-entity” and “co-packaged” combination products is more complex. Thus, the final rule also sets forth a transparent and streamlined regulatory framework for manufacturers to use when demonstrating compliance with CGMP requirements for such products. Specifically, manufacturers may demonstrate compliance with CGMPs for “single-entity” and “co-packaged” combination products in one of two ways: (1) by demonstrating compliance with the specifics of all CGMP requirements applicable to each of the constituent parts included in the combination product; or (2) if the combination product contains both a drug and a device, demonstrating compliance with either drug CGMPs or quality system regulations for devices, in addition to other requirements set forth in the final rule. “Single-entity” combination products are products comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single-entity. “Co-packaged” combination products are two or more separate products packaged together in a single package or as a unit and comprised two regulated components. The rule becomes effective on July 22, 2013.

FDA Announces 2013 Generic Drug Active Pharmaceutical Ingredient and Finished Dosage Form Facility User Fee Rates

This post was written by Jennifer Pike.

The FDA has announced the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facility user fee rates for fiscal year 2013. The API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more APIs identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II API master file referenced in such generic drug submission. The API facility fee for 2013 for domestic facilities is $26,458, while the API facility fee for foreign facilities is $41,458. The FDF facility fee is owed by each person that owns a facility which is identified or is intended to be identified, in at least one generic drug submission that is pending or approved, to produce one or more finished dosage forms of the human generic drug. The FDF facility fee for 2013 for domestic facilities is $175,389, and the FDF facility fee for foreign facilities is $190,389. Both API and FDF fees are due on March 4, 2013. FDA is authorized to collect these fees, among others, under the Generic Drug User Fee Amendments of 2012.

FDA Requests Comments on Review of Medical Device Submissions

This post was written by Jennifer Pike.

The FDA has announced an opportunity for public comment on the statement of work for an assessment for the process of review of medical device submissions. Under the Medical Device User Fee Act of 2012 (MDUFA III), which gives FDA the authority to collect device user fees from industry for 2013-2017, FDA has committed to reaching certain performance goals. Among others, FDA is committed to participate, with the device industry, in a comprehensive assessment of the process for the review of device applications. The assessment will be conducted in two phases by a private, independent contractor. FDA is providing a comment period on the statement of work before requesting proposals for the assessment. Comments should be submitted in writing or electronically, at www.regulations.gov, by February 4, 2013.

FDA Issues Final Guidance Documents on Drug and Medical Device Submissions

This post was written by Jennifer Pike.

On January 2, 2013, the FDA issued three final guidance documents related to drug and medical device submissions. The first guidance, Acceptance and Filing Reviews for Premarket Approval Applications, is intended to clarify the criteria for accepting and filing a premarket approval application (PMA) to assure the consistency of FDA’s acceptance and filing decisions. The guidance is applicable to original PMAs and PMA panel-track supplements reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The second guidance, eCopy Program for Medical Devices Submissions, explains the new electronic copy (eCopy) Program for medical devices submissions, provides the standards for a valid eCopy, and identifies the submission types that must include an eCopy in accordance with such standards for the submission to be processed and accepted for review by FDA. The final guidance, Refuse to Accept Policy for 510(k)s, explains the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete. The guidance is applicable to 510(k)s reviewed by CDRH and CBER.Comments regarding the guidances may be submitted at any time.

FDA Releases Draft Guidance Documents on Providing Submissions in Electronic Format

This post was written by Jennifer Pike.

The FDA released draft guidance on January 3, 2013 entitled Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications. The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act, which amended to Federal Food, Drug, and Cosmetic Act to require that certain regulatory submissions be submitted in electronic format. The guidance describes how FDA plans to implement this requirement. According to the guidance, requirements for electronic submission will be phased in on the following schedule: (1) 24 months after publication of the final version of this draft guidance, the requirements will apply to new drug application (NDA), abbreviated new drug application (ANDA), and biologics license application (BLA) submissions, and (2) 36 months after publication of the final guidance, the requirements will apply to investigational new drug application (IND) submissions. Comments will be accepted until March 4, 2013. A second draft guidance document, Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning, is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the individual study site level. Such datasets facilitate the use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. The guidance describes a recommended electronic format for the datasets to be submitted voluntarily in NDA, BLA, and NDA and BLA supplemental applications submitted to CDER. Comments may be submitted to www.regulations.gov by February 19, 2013.

FDA Draft Guidance Addresses Clinical Trial Enrichment

This post was written by Jennifer Pike.

The FDA is seeking comments on draft guidance related to clinical trial enrichment: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The document is designed to provide guidance to industry on enrichment strategies that can be used in clinical trials intended so support effectiveness and safety claims in NDAs and BLAs. According to FDA, enrichment could lead to smaller studies, lower development costs, and help develop more personalized medicine. The guidance defines and discusses three types of enrichment strategies: decreasing heterogeneity, predictive enrichment, and prognostic enrichment. The guidance also discusses general clinical trial design considerations, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. Comments may be submitted at www.regulations.gov until February 15, 2013.

Older Entries

January 11, 2013 — FDA Issues Two Final Guidances on Safety Reporting Requirements

January 11, 2013 — FDA To Hold Workshop on Accessible Standardized Medical Device Labeling (April 29-30)

November 28, 2012 — FDA Addresses Food and Drug Administration Safety and Innovation Act (FDASIA) Implementation

November 28, 2012 — Upcoming FDA Public Meeting: Framework for Pharmacy Compounding/State and Federal Roles (Dec. 19)

October 31, 2012 — FDA Issues Generic Drug User/Backlog Fee Notices

September 27, 2012 — FDA Meetings on Patient-Focused Drug Development Initiative

September 6, 2012 — FDA Final Rule Implementing Device Registration and Listing Requirements

September 5, 2012 — FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

July 31, 2012 — Medical Device User Fee Rates for FY 2013

July 16, 2012 — FDA Proposes Unique Device Identification System for Medical Devices

May 11, 2012 — FDA Final Rule on Disqualification of Clinical Investigators

May 11, 2012 — FDA Issues Final Rule on Sterility Testing of Biological Products

February 10, 2012 — Final Rule Regarding Labeling Requirements for Products Held in Strategic National Stockpile

January 25, 2012 — FDA Seeks Comments on Prescription Drug Promotion Survey

January 4, 2012 — FDA Rule Expands Drug Manufacturer Notification Requirements for Potential Drug Shortages

December 13, 2011 — FDA Publishes Notice on Biosimilar Biological Product User Fees

November 10, 2011 — FDA Announces Review of Bar Code Final Rule

October 25, 2011 — FDA Proposes Amendments to Orphan Drug Rules

October 12, 2011 — CMS and FDA Publish Parallel Review Pilot Program Notice

September 1, 2011 — Comment Period Extended for Proposed Rule Regarding Human Subject Protections

July 26, 2011 — FDA Issues Guidance and Final Rule Regarding Focused Ultrasound Stimulators for Aesthetic Use

July 18, 2011 — FDA Issues Draft Guidance Related to IVD Companion Diagnostic Devices

July 18, 2011 — FDA Proposed Rule Would Eliminate Certain Drug Pedigree Requirements

June 28, 2011 — FDA Proposed Rule to Amend Sterility Test Requirements for Biologicals

May 31, 2011 — FDA Publishes Draft Guidance on Financial Disclosures by Clinical Investigators

May 13, 2011 — FDA User Fee Program for Biosimilar and Interchangeable Biological Product Applications

May 13, 2011 — FDA Solicits Comments on Effectiveness of Regulations

May 13, 2011 — FDA Publishes Draft Guidance on Reprocessing of Reusable Medical Devices

May 13, 2011 — FDA Reestablishes Medical Imaging Drugs Advisory Committee

April 29, 2011 — FDA Publishes Final Rule on Constituent Materials in Biologics

March 7, 2011 — FDA Finalizes Medical Device Data Systems Rule

January 13, 2011 — FDA Updates Informed Consent Regulations to Require Statement on Government Databank Disclosure

January 13, 2011 — FDA Issues Advanced Notice of New GLP Rules for Non-clinical Studies

December 15, 2010 — FDA Requests Notification of Intent to Participate in Medical Device User Fee Reauthorization Process

December 15, 2010 — FDA Seeks Comments on Clinical Benefit Information in Professional Labeling, Direct-to-Consumer Print Advertisements

November 29, 2010 — FDA Issues Draft Guidance Document on Manufacturer Communications to Health Care Providers

November 15, 2010 — FDA Reopens Comment Periods on Generic Drug User Fee Program, PDUFA Reauthorization

October 15, 2010 — FDA Enters Agreement to Support WHO with Counterfeit Drug Efforts

October 15, 2010 — FDA Seeks Comment on 5 Year Strategic Priority Plan

October 5, 2010 — FDA to Hold Public Meeting on ACA Biosimilars Pathway - November 2-3, 2010

September 30, 2010 — FDA Issues Final Rule, Draft Guidance on Clinical Trial Safety Reporting Requirements

September 17, 2010 — Parallel CMS/FDA Review of Medical Products

August 13, 2010 — Memorandum of Understanding Between FDA and CMS

August 13, 2010 — FDA Announces Medical Device User Fees for FY 2011, Upcoming Meeting (Sept. 12)

August 13, 2010 — FDA Proposes Changes to the 510(k) Program; Seeks Public Comment

August 13, 2010 — FDA Withdraws Direct Final Rule Requiring the Submission of Information on Pediatric Uses of Devices

April 16, 2010 — FDA Issues Final Regulations Requiring the Submission of Information on Pediatric Populations for Devices

March 31, 2010 — FDA Issues Proposed Rule on Clear and Conspicuous Standard for DTC Advertisements

March 31, 2010 — FDA Issues Proposed Rule on Implementation of Device Registration and Listing Requirements

March 31, 2010 — FDA Issues Final Regulations Restricting the Sale and Distribution of Cigarettes

February 26, 2010 — FDA Proposed Rule on Reporting Information on Falsification of Data

January 13, 2010 — Proposed Rule Amending Informed Consent Disclosure

October 15, 2009 — FDA Postmarketing Safety Reporting for Combination Products

September 23, 2009 — Current Good Manufacturing Practice Requirements for Combination Products

September 23, 2009 — Promotion of Medical Products Using the Internet and Social Media

September 23, 2009 — FDA Guidance Documents

September 23, 2009 — Pilot Program on Quality Information for Biotechnology Products

September 23, 2009 — Drug/Biologics Firm Performance Regarding Postmarketing Requirements

September 4, 2009 — FDA Proposed Rules on Electronic Reporting of Adverse Drug and Device Events

September 4, 2009 — FDA Comment Solicitation on Enhancing FDA Transparency

August 17, 2009 — FDA Issues Final Rules on Patient Access to Investigational Drugs

August 17, 2009 — FDA Review of Post-Inspection Responses

July 28, 2009 — NDA Reporting Requirements

July 2, 2009 — FDA Seeks Comments on New Tobacco Law

June 24, 2009 — FDA Comment Solicitation on Drug Advertising

May 27, 2009 — FDA Seeks Comments on Presenting Risk Information in Drug and Device Promotion

May 7, 2009 — Revocation of Biologics Licenses

April 7, 2009 — Generic Animal Drug User Fees

March 6, 2009 — Maximum FDA Civil Money Penalty (CMP) Amounts

January 27, 2009 — Good Reprint Practices

January 27, 2009 — Secure Supply Chain Pilot Program

January 27, 2009 — Increasing Clinical Trial Enrollment; Comments Requested

January 27, 2009 — Submission of Bioequivalence Data

December 22, 2008 — FDA Study on DTC Ad Coupons

December 22, 2008 — FDA Grants for Orphan Product Studies

December 8, 2008 — FDA Study on DTC Drug Advertising

November 25, 2008 — Draft FDA Guidance: Evaluating Drug/Biological Proprietary Names

November 25, 2008 — Draft FDA Guidance: Process Validation: General Principals and Practices

November 17, 2008 — Maximum CMP Amounts for FDA Authorities

November 17, 2008 — FDA/CBER Public Advisory Committee Representatives

October 30, 2008 — Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products

October 7, 2008 — FDA Authorized Generics Reporting Requirements

September 10, 2008 — CGMPs for Finished Pharmaceuticals

September 10, 2008 — FDA Guidance: Bioequivalence (BE) Recommendations and Drug Clinical Trials

August 22, 2008 — Labeling Changes for Approved Drugs, Biologics, and Medical Devices

August 14, 2008 — FDA Advisory Committee Guidance

August 14, 2008 — FDA Drug/Device User Fees

August 14, 2008 — FDA/OTC Advertising Review

July 29, 2008 — Animal Drug User Fees

July 29, 2008 — FDA CGMP Rule Regarding Investigational Drugs

July 14, 2008 — FDA Rule/Guidance on Investigational New Drugs Intended for Use in Clinical Trials

July 8, 2008 — Animal Drug User Fees

July 8, 2008 — FDA Biotechnology Quality Pilot Program

July 8, 2008 — PDUFA IV Information Technology Plan

July 8, 2008 — FDA Bioequivalence Recommendations

June 20, 2008 — House Approves Medicaid Rule Moratorium, Increased FDA Funding

June 19, 2008 — Medical Device Reporting Requirements

June 19, 2008 — OIG Report on FDA Generic Drug Reviews

June 3, 2008 — FDA Rule on Drug Label Pregnancy Information

June 3, 2008 — FDA Sentinel Initiative