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FDA’s CDER Previews 2016 Guidance Agenda


Pharmaceutical Executive

January 25, 2016.

On Jan. 22, 2016, FDA’s Center for Drug Evaluation and Research (CDER) announced their agenda for new and revised draft guidance documents the center plans on publishing in 2016. Of the approximately 100 draft guidance documents the center plans on publishing in 2016, the majority address clinical, quality, and procedural issues.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

Drug safety

  • 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

Generic drugs

  • 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. 

Source: FDA

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