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 Jennifer Pike.

A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products. Further, the draft guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting package to FDA. The draft guidance provides good meeting management practices that are intended to provide consistent procedures that will promote well-managed meetings and ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately. The following five meeting types are described in the draft guidance: (1) Biosimilar Initial Advisory meeting (initial assessment of whether licensure is feasible for product, and if so, general advice on development of product); (2) biosimilar biological product development (BPD) Type 1 meeting (meeting that is necessary for an otherwise stalled BPD program to proceed); (3) BPD Type 2 meeting (meeting to discuss a specific issue or questions where FDA will provide targeted advice); (4) BPD Type 3 meeting (in-depth data review and advice regarding on-going BPD program); and (5) BPD Type 4 meeting (meeting to discuss format and content of application). Comments on the draft guidance should be submitted in writing, or electronically at www.regulations.gov, by May 31, 2013. 

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This post was written by Jennifer Pike.

FDA has issued a new draft guidance document entitled “Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.” The document provides guidance to industry and FDA staff on the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product that is approved under one marketing application (i.e., a biologics licensing application, a new drug application, or a premarket approval application). FDA regulations describe requirements related to postmarket submissions for changes to stand-alone products, but do not expressly address submissions for changes to combination products. The guidance intends to clarify and provide consistency with regard to the latter. Specifically, the document provides tables that may be helpful in determining what type of submission to use for a postmarket change to a constituent part of a combination product where the regulatory identity of the modified constituent part differs from the application type under which the combination product is approved. Comments on the draft guidance should be submitted, in writing or electronically, at www.regulations.gov by April 22, 2013.

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This post was written by Jennifer Pike.

The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in determining whether the proposed research satisfies the criteria for IRB approval. Specifically, the guidance addresses the IRB’s role in reviewing: (1) the qualifications of investigators; (2) the adequacy of research sites; and (3) the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed. Many of the recommendations in the guidance have appeared in other FDA guidance documents or have been communicated to IRBs who have contacted the agency directly about these issues, but FDA has compiled the information here to ensure that all IRBs are aware of and have access to it. When finalized, this guidance will supersede Question 56 in FDA’s January 1998 guidance Institutional Review Board Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.

The second draft guidance, Draft Guidance for Industry: Electronic Source Data in Clinical Investigations, provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This guidance revises and updates the draft guidance Electronic Source Documentation in Clinical Investigations. The draft guidance addresses source data (from clinical investigations) used to fill the predefined fields in an electronic case report form (eCRF), according to protocol , and discusses the following topics related to electronic source data: (1) identifying and specifying authorized source data originators; (2) creating data element identifiers to facilitate sponsors, FDA, and other authorized parties in examining the audit trail of data; (3) capturing source data into the eCRF using either manual or electronic capture methods; and (4) investigator responsibilities with respect to reviewing and retaining electronic data. Comments on both guidance documents will be accepted at www.regulations.gov until January 22, 2013.

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This post was written by Jennifer Pike.

On December 13, 2012, the FDA issued two draft guidance documents related to product safety and risk minimization. The first guidance, Design Considerations for Devices Intended for Home Use, is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. The guidance identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Factors to consider in designing and developing medical devices for home use include the physical environment, the user, the device or system, the labeling, and the utilization of human factors. The guidance applies to both prescription and over-the-counter medical devices that are intended for home use. The second guidance, Safety Considerations for Product Design to Minimize Medication Errors, provides sponsors of IND applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The recommendations in the guidance are intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. This draft guidance is the first in a series of three planned guidance documents to minimize risks contributing to medication errors. Comments on both guidance documents should be submitted to www.regulations.gov by March 13, 2013.

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This post was written by Jennifer Pike.

On September 24, 2012, the Food and Drug Administration (FDA) published two notices in connection with its patient-focused drug development initiative. The first notice announces a public meeting and an opportunity for public comment related to the initiative, and the second notice requests that patient stakeholders notify FDA of their intention to participate in periodic consultation meetings on process issues related to the initiative. By way of background, under the Prescription Drug User Fee Act, FDA must meet standards related to enhanced patient representation in drug regulation decision-making. The patient-focused drug development initiative fulfills this requirement. Under this initiative, FDA will conduct public meetings to consider 20 different disease areas. The first of these meetings, at which FDA will provide an overview of the initiative, will be held on October 25, 2012. Attendees will be invited to comment on FDA’s preliminary list of nominated diseases for the initiative and the criteria used to develop the list. The registration deadline is October 18, 2012, and comments may be submitted by November 1, 2012.  In addition to public meetings to consider disease areas, FDA will hold meetings with patient stakeholders to discuss key process questions for patient-focused drug development. The deadline for stakeholders to notify FDA of their intention to participate is October 3, 2012, and the first meeting will be held on October 10, 2012.

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This post was written by Erin Janssen.

On August 27, 2012, FDA issued draft guidance documents for industry entitled "Self-Identification of Generic Drug Facilities, Sites, and Organizations" and "Generic Drug User Fee Amendments of 2012: Questions and Answers." The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. The GDUFA also is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, and enable FDA to assess user fees to support enhancements to FDA’s generic drugs program. The first draft guidance document is intended to assist industry as it prepares to meet the law’s self identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. The second guidance document answers common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. To be considered before FDA begins work on the final versions of these documents, comments should be submitted by October 26, 2012.

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This post was written by Erin Janssen.

The FDA has issued guidance on FY 2013 medical device user fees for small businesses. The guidance explains how a business may qualify as a “small business” and pay most FY 2013 medical device user fees at substantially discounted rates. While the guidance is substantively the same as the guidance provided for FY 2012, the following new considerations are particularly significant:

• The guidance explains that there is no small business discount for the establishment registration fee. If this is the only fee a business expects to pay during FY 2013, it should not submit an FY 2013 Small Business Qualification Certification.
• A foreign business may qualify as a small business, even if it has not submitted a federal (U.S.) income tax return.

As of September 30, this document supersedes “Guidance for Industry, FDA, and Foreign Governments: FY 2012 Medical Device User Fee Small Business Qualification and Certification,” as issued on May 25, 2012.

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This post was written by Erin Janssen.

On August 13, 2012, FDA released draft guidance for public comment entitled “Refuse to Accept Policy for 510(k)s.” The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete, which determines whether it should be accepted for substantive review. The guidance is applicable to 510(k)s reviewed by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. To ensure that comments are considered before the agency begins work on the final version of the guidance, interested parties should submit comments on the draft guidance by September 27, 2012.

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This post was written by Erin Janssen.

FDA has announced the release of a draft guidance document concerning the necessary elements and contents of a complete premarket approval (PMA) application and the key decisions that are made during the filing process. The draft guidance applies to all devices reviewed in a PMA application and, if accepted as final, will replace FDA's original 2003 PMA guidance review criteria and checklist. The draft guidance is intended to enhance the consistency of acceptance and filing decisions and to help applicants better understand the types of information FDA needs to conduct a substantive review of a PMA. Unlike FDA's original 2003 guidance on PMA reviews, the new draft guidance separates the criteria review for PMA filings into two areas: (1) acceptance criteria, and (2) filing criteria. During an acceptance criteria review, the draft guidance states that FDA will review the completeness of the application and inform the applicant in a written response within the first 15 calendar days of receipt of the application whether any elements are missing, and if so, identify the missing elements. Comments on the draft guidance should be submitted to the FDA by September 14, 2012.

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This post was written by Erin Janssen.

On July 13, 2012, FDA issued draft guidance entitled "Medical Devices: The Pre-submission Program and Meetings with FDA Staff." The new draft guidance outlines recommendations for sponsors and FDA staff and managers as well as expected timeframes for scheduling meetings. In addition, the guidance describes the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff, either as the preferred method of feedback in response to a pre-submission request, or to discuss to an existing regulatory submission. Finally, the guidance recommends how to prepare for meetings with FDA staff. When final, the new guidance document will supersede 1999 guidance entitled “Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1.” Although comments may be submitted on any guidance at any time, interested parties should submit comments on the draft guidance by October 11, 2012. 

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This post was written by Erin Janssen.

The FDA has published a Small Entity Compliance Guide entitled "Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications." This guidance is intended to help small businesses understand and comply with the requirements of the October 28, 2008 final rule on labeling of drugs with a toll-free number for adverse event reporting. The guidance describes certain requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule.

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This post was written by Erin Janssen.

The FDA has released additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new BE recommendations were developed using the process described by FDA in a June 11, 2010 notice. The public is encouraged to submit comments on the new recommendations by August 13, 2012. 

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This post was written by Erin Janssen.

The FDA has published a notice announcing the availability of draft guidance on "Considerations When Transferring Clinical Investigation Oversight to Another IRB." This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. This guidance also addresses questions previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred. Comments are due by August 13, 2012.

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This post was written by Erin Janssen.

The FDA recently published a guidance document entitled "S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use." This guidance combines and replaces two ICH guidances, S2A Specific Aspects for Regulatory Genotoxicity Tests for Pharmaceuticals (ICH S2A guidance) and S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (ICH S2B guidance). The purpose of the revision is to provide guidance on optimizing the standard genetic toxicology battery for prediction of potential human risks, and on interpreting results, with the goal of improving risk characterization for carcinogenic effects that have their basis in changes in the genetic material. The revised guidance describes internationally agreed-upon standards for follow-up testing and interpretation of positive results in vitro and in vivo in the standard genetic toxicology battery, including assessment of nonrelevant findings. This guidance is intended to apply only to products being developed as human pharmaceuticals.

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This post was written by Erin A. Janssen.

The FDA has published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during pre-market review.  Specifically, the guidance: (i) outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process; (ii) provides manufacturers a tool that explains the various principal factors considered by the agency during the review of premarket approval applications, the regulatory pathway for high-risk medical devices, and de novo petitions; and (iii) describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device. The guidance applies to both diagnostic and therapeutic devices. The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment. 

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This post was written by Erin A. Janssen.

The FDA has announced that it is seeking expert scientific and clinical advice on the risks and benefits of MoM hip systems, as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. The agency is currently considering whether to make MoM hip systems subject to more rigorous testing and premarket review requirements. FDA will discuss these issues at an expert advisory panel meeting on June 27-28, 2012. 

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This post was written by Erin A. Janssen.

According to an April 24, 2012 Center for Drug Evaluation and Research (CDER) report, a strengthened and modernized post-market drug safety program has resulted in a substantial improvement in FDA’s oversight of drugs once they reach the American public. The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that CDER contend give the same priority to post market drug safety monitoring as to premarket drug review. The report says CDER is also delivering earlier, more effective drug safety information to the public. CDER's efforts include the development of new scientific tools to enhance detection of potential drug safety issues that occur once a drug is on the market and new methods for planning, managing, tracking, and communicating about those issues.

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This post was written by Erin A. Janssen.

On April 23, 2012, FDA released its “Global Engagement Report,” detailing the strategies FDA is using to transform from a domestic to a global public health agency.  The report describes how the agency is ensuring that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically. The report also outlines strategies the FDA is using in partnership with other agencies and organizations around the world to strengthen global regulatory capacity-building efforts; develop and harmonize science-based regulatory standards; increase awareness about the importance of regulatory systems; and share information globally to facilitate rapid identification of and response to public health emergencies. 

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The FDA has released draft guidance on implementation of the drug sample transparency reporting provisions of section 6004 of the ACA. Under this provision, beginning April 1, 2012 and annually thereafter, each manufacturer and authorized distributor of record (ADR) of a prescription drug for which payment is available under Medicare or Medicaid must submit to the Secretary, for the preceding year, the identity and quantity of drug samples requested and distributed under the federal Food, Drug, and Cosmetic Act, aggregated by the name, address, professional designation, and signature of the practitioner making the request, or of any individual who makes or signs for the request on behalf of the practitioner (and by any other category of information determined appropriate by the Secretary). Notably, the FDA is has announced that, notwithstanding the statutory deadline, FDA does not intend to object until at least October 1, 2012, if manufacturers and ADRs do not submit information under those reporting provisions. The FDA intends to provide notice before revising its exercise of discretion with respect to compliance, and the agency expects to issue additional guidance concerning the section 6004 later in 2012. The draft guidance also notifies covered entities that (1) FDA plans to use its Electronic Submission Gateway for submissions under section 6004; (2) revisions to allow the Gateway to receive such submissions should be complete by April 1, 2012; and (3) if covered entities wish to make submissions despite FDA’s compliance policy, the draft guidance provides information about accessing the Gateway.  A Federal Register notice announcing the availability of the guidance will be published April 3, and comments will be accepted for 60 days thereafter.

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This post was written by Erin A. Janssen.

The FDA has released draft guidance entitled “Classifying Significant Postmarket Drug Safety Issues.”  This draft guidance describes FDA’s current approach to classifying a significant postmarket drug safety issue as a “priority” tracked safety issue (TSI) or a “standard” TSI, with the capability of elevating some priority TSIs to an “emergency” status. The Center for Drug Evaluation and Research seeks to establish a formal framework for assessing the relative urgency of TSIs, so that CDER can direct resources more effectively toward the issues that pose the greatest potential risk for patients. This framework will classify TSIs as “priority” or “standard” for CDER review. In addition, the Center will recognize a special “emergency” category for certain priority TSIs. The use of a formal framework is intended to ensure that staff working in different offices across CDER reaches similar conclusions about the relative urgency of TSIs. It also will inform CDER decisions about public drug safety communications, so that health care practitioners and patients receive timely information about safety risks with the greatest public health significance. Written comments are due May 8, 2012.

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