FDA’s CDER Unveils Plans for 2016 Guidance Documents

Posted 22 January 2016 By Zachary Brennan


The guidance agenda for the next fiscal year from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reveals a lot of new advice on generics, pharmaceutical quality, off-label communications and other recommendations carried over from 2015, particularly on the implementation of the Drug Supply Chain Security Act (DSCSA).

The 15 categories of guidance documents planned for 2016 range from advertising (including a potentially controversial one on communications on unapproved, unlicensed or uncleared uses of approved, licensed or cleared human drugs, biologics, animal drugs and medical devices) to clinical (meta-analysis on randomized controlled trials) to safety (new guidance on post-market reporting for biologics and vaccines).

The total of 102 planned guidance documents is slightly higher than the 90 CDER planned to release in 2015 and considerably more than what was planned for 2014 and 2013.

And included on both 2015 and 2016 lists: The same three biosimilar guidance documents (on interchangeability, labeling and statistical approaches for evaluating similarity data), one on Internet, social media and promotional labeling, one on pregnant women in clinical trials and one on multiple endpoints in clinical trials, among others.

As for generic drug companies, FDA will release new draft guidance on: “General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products,” “Three-Year Exclusivity Determinations for Drug Products,” and “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn.”

Also included in this year’s list are new guidance plans for different types of treatment, including those for ulcerative colitis (also included in 2015’s list), revised guidance on allergic rhinitis products and exocrine pancreatic insufficiency drugs.

On the DSCSA implementation front, which has already begun, FDA plans six guidance documents, all except one (Field Alert Submissions) of which were included in 2015’s list:

  • Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers;
  • Products Eligible for Grandfather Status;
  • Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs;
  • The Product Identifier for Human, Finished, Prescription Drugs;
  • Verification Systems for Prescription Drugs;
  • Waivers, Exceptions and Exemptions from Product Tracing Requirements; and
  • Field Alert Report Submissions.

Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016


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Tags: CDER guidance, 2016 guidance documents, biosimilar guidance

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