FDA: CDER-Liste aller geplanten Leitlinien 2020

Die diesjährige Liste des CDER (Center for Drug Evaluation and Research) mit den zur Veröffentlichung vorgesehenen Leitlinien umfasst 14 Kategorien mit insgesamt 89 Dokumenten. 

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

Die Kategorien beinhalten folgende Dokumente:

Pharmaceutical Quality CGMP

• PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft

Pharmaceutical Quality/CMC

• ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
• Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
• 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
• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics
• The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls

Pharmaceutical Quality/Microbiology

• Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing
• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics

Die fett markierten Dokumente fanden sich bereits im letzten Jahr auf der Liste. Die vollständige CDER-Liste finden Sie hier.

Quelle:

FDA: Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2020