FDA: l’agenda delle pubblicazioni 2021

Ultimo aggiornamento: 2 anni fa

Il Center for Drug Evaluation and Research (CDER) di FDA ha pubblicato l’elenco dei documenti previsti per la pubblicazione nel 2021. Si tratta di 105 documenti, divisi in 18 categorie (quattro più dello scorso anno).

La pubblicazione di molti dei documenti GMP rilevanti era in programma per il 2020 ma la situazione di emergenza Covid ha rallentato i lavorie la successiva emissione.

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​

Fonte

FDA: CDER Guidance Agenda New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021