Damit sind es vier Kategorien und 16 Dokumente mehr als im Vorjahr. Dokumente, die sich bereits im letzten Jahr auf der Liste befanden, sind im Folgenden hervorgehoben. Sie stellen klar die Mehrzahl dar. Auch hier zeigen sich also die durch die Corona-Pandemie entstandenen Verzögerungen in der Bearbeitung.

GMP-relevant sind die Kategorien Pharmaceutical Quality CGMP und Pharmaceutical Quality/CMC sowie Pharmaceutical Quality/Microbiology.

Pharmaceutical Quality CGMP

• PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
• Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

Pharmaceutical Quality/CMC

• ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
• Chemistry Manufacturing and Controls Considerations for Individualize Antisense Oligonucleotide (ASO) Therapies
• Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations
• ICH Q12, General Considerations for FDA Implementation
• Inspection of Injectable Products for Visible Particulates
• Quality Considerations for Topical Ophthalmic Drug Products
• Quality and Stability Testing of Drug Substances and Drug Products for NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
• Risk Management Plans to Mitigate the Potential for Drug Shortages
• Benefit-Risk Considerations for Product Quality Assessments

Pharmaceutical Quality/Microbiology

• Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing

FDA: CDER Guidance Agenda New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021​