Regulatory News

CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

The 102 draft guidance documents slated for release in 2017 are on par with the number expected in 2016 (also 102 draft documents), but up significantly from the 60 guidance documents from 2013 and about 70 from 2014, and as in previous years, the largest chunk of new draft guidances will be procedural.

CDER plans to release 28 procedural draft guidelines in 2017, including ones on refuse to file issues with new drug application and biologics license applications, as well as several related to Risk Evaluation and Mitigation Strategies.

On the quality/chemistry manufacturing and controls (CMC) front, new drafts are expected on CMC postapproval manufacturing changes for specified biologics in annual reports, visual inspection of injectable drugs and in-vitro methods for the evaluation of abuse-deterrent properties of opioids.

As far as drafts that will be revised in 2017, FDA points to 27 documents (up from 21 revisions planned for 2016), including nine that were included on both the 2016 and 2017 lists, including:

• Adaptive Design Clinical Trials for Drugs and Biologics
• Pediatric Oncology Product Development
• Clinical Drug Interactions Studies: Study, Design, Data Analysis, Implications for Dosing and Labeling Recommendations
• Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling
• ANDA Submissions – Content and Format of Abbreviated New Drug Applications
• Drug Master Files
• Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation
• Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100
• Regulatory Considerations: Complying with the Pediatric Research Equity Ac
   
  t (PREA) & Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals Act (BPCA)

Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017