Tag Archives: Other FDA Developments

Draft FDA Guidance Recommends Cybersecurity Risk Assessments and Management Plans for Premarket Medical Device Submissions

The Food and Drug Administration (FDA) has announced the availability of a new draft guidance document entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The draft guidance identifies cybersecurity issues that medical device manufacturers should consider in preparing premarket submissions for medical devices – including Premarket Notifications (510(k)), Premarket Approval Applications … Continue Reading

FDA Issues New Draft Guidance Documents on Access to Investigational Drugs

On May 9, 2013, the Food and Drug Administration (“FDA”) announced the availability of two new draft guidance documents answering common questions on FDA’s implementation of regulations related to access to investigational drugs. The first draft guidance, entitled “Charging for Investigational Drugs Under an IND – Qs & As,” addresses FDA’s implementation of 21 C.F.R. … Continue Reading

FDA Draft Guidance on Biosimilar Product Development Now Available

A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological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 Further, the draft guidance assists sponsors and applicants in generating … Continue Reading

New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

FDA has issued a new draft guidance document entitled “Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.”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 … Continue Reading

FDA Issues Two New Draft Guidance Documents Related to the Conduct of Clinical Trials

The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the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 … Continue Reading

New FDA Draft Guidance Documents Address Product Safety and Risk Minimization

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. … Continue Reading

FDA Meetings on Patient-Focused Drug Development Initiative

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 … Continue Reading

Draft Guidance Regarding Self-Identification of Generic Drug Facilities and Q&A on Generic Drug User Fee Amendments

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 … Continue Reading

FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

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 … Continue Reading

FDA Issues Guidance for Comment on Refuse to Accept Policy for 510(k)s

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 … Continue Reading

FDA Issues Draft Guidance Regarding Acceptance & Filing Review for PMA Applications

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 … Continue Reading

FDA Draft Guidance the Medical Device Pre-Submission Program/Meetings with FDA Staff

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 … Continue Reading

FDA Small Entity Compliance Guidance: Toll Free Number Labeling for Drugs

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 … Continue Reading

FDA Draft Guidances Describe Product-Specific Bioequivalence Recommendations

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, … Continue Reading

FDA Draft Guidance Document on Transferring Clinical Investigation Oversight to Another IRB

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 … Continue Reading

FDA Guidance Addresses Genotoxicity Testing and Data Interpretation for Human Drugs

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 … Continue Reading

FDA Guidance on Medical Device Pre-market Approval

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 … Continue Reading

FDA Reports on Post-Approval Drug Safety Monitoring

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 … Continue Reading

International Collaboration Highlighted in FDA Global Engagement Report

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 … Continue Reading

FDA Announces Delayed Enforcement of ACA Drug Sample Distribution Reporting Requirement

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 … Continue Reading

FDA Draft Guidance on Classifying Significant Postmarket Drug Safety Issues

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 … Continue Reading

FDA Issues Guidance Update on Communication to the Public about Drug Safety

This post was written by Erin A. Janssen. The FDA has released draft guidance entitled “Drug Safety Information—FDA’s Communication to the Public,” which updates and revises March 2007 guidance on this issue.  It describes FDA’s current approach to communicating to the public important drug safety information, including emerging drug safety information, and the factors that … Continue Reading

Draft FDA Guidance Targets Direct-to-Consumer Television Marketing

This post was written by Erin A. Janssen. FDA has released draft guidance for industry entitled “Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad Pre-Dissemination Review Program.”  The draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements provision of the … Continue Reading
LexBlog