New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015

Rx-360 has highligted that the FDA has released a new list of guidance documents CDER plans to publish in 2015. Based on this list of expected guidances, CMC, manufacturing and quality appear to be areas of focus for CDER in 2015. Highlights on the list includes

• Six (6) guidance documents on track and trace as part of the Drug Supply Chain Security Act (DSCSA), including verification systems for drugs, getting a waiver from product tracing requirements, and products eligible for grandfather status.

• Quality Metrics and Risk-Based Inspections.

• Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.

• CGMP Data Integrity Questions and Answers.

• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing and Controls Information.

Click here for the complete list of CMC/quality-related expected guidance documents.
 

Note that although FDA intends to issue these documents, they frequently do not appear in the public domain in the given year.  As such, they should be treated as documents that may issue but there is no guarantee they will.