CDER Announces 2015 Guidance Plan

FDA’s Center for Drug Evaluation and Research (CDER) has released its guidance agenda for 2015. Among the new and revised draft guidance documents are eight regarding biopharmaceuticals, including four on biosimilarity. Pharmaceutical quality is the hot topic for CDER in 2015 with 16 guidance documents planned for the year, including guidance on quality metrics and elemental impurities. Drug safety, generic drugs, and electronic submissions are topics to be addressed in the new year.

A few noteworthy guidance documents for 2015 include:

• Quality Metrics and Risk-Based Inspections

• Elemental Impurities in Drug Products Marketed in the United States

• Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)

• Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products-General Considerations 

• Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

• Labeling for Biosimilar Biological Products

• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

• Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)

• NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions

• Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products-Content and Format

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

For a complete list of guidance documents CDER has planned for 2015, visit FDA.gov.

Source: FDA.gov