GMP Aktuell

31.01.2020

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



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