On Jan. 22, 2016, FDA’s Center for Drug Evaluation and Research (CDER) announced their agenda for new and revised draft guidance documents the center plans on publishing in 2016. Of the approximately 100 draft guidance documents the center plans on publishing in 2016, the majority address clinical, quality, and procedural issues. Other popular pharmaceutical topics addressed include generic drugs and labeling.
The following are some highlights from the agenda by category.
Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products–General Considerations
Considerations in Demonstrating Interchangeability With a Reference Product
Labeling for Biosimilar Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity
Format and Content of Proposed Risk Evaluation and Mitigation Strategies
Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines
NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
CGMP Data Integrity Questions and Answers
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
Pharmaceutical quality/chemistry, manufacturing and controls (CMC)
Elemental Impurities in Drug Products Marketed in the United States
Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
Nanomaterials in Drug and Biologic Products
Quality Metrics Technical Conformance Guide
180 Day Exclusivity: Guidance for Industry
Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs
Three-Year Exclusivity Determinations for Drug Products
ANDA Submissions–Identifying Reference Products
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
REMS Assessment: Planning and Reporting
Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
The agenda also includes a variety of Drug Supply Chain Security Act (DSCSA) implementation and Pediatric Research Equity Act (PREA) guidance documents.
The full list can be found on the FDA.gov website.