Ressources numériques en sciences humaines et sociales OpenEdition Nos plateformes OpenEdition Books OpenEdition Journals Hypothèses Calenda Bibliothèques OpenEdition Freemium Suivez-nous

Food and Drug Administration (FDA) Revision of USP Chapter on Gene Therapy Medicinal Products (Catapult’s regulatory round-up – October 2024)

This chapter covers the clinical applications, manufacturing processes and analytical methods of gene therapy products, which are constantly evolving.

The current amendment proposals include, for example, the following points:

  • Delete the reference to “Safety Tests-Biologicals” in “Biological Reactivity Tests, in vivo” from the chapter
  • Delete the Safety Tests-Biologicals section from Chapter <88>, as the corresponding FDA Code of Federal Regulations, 21 CFR §610.11, was revoked on August 3, 2015.
  • Some editorial changes.

Please find further information here.

Text published on the 5th of November 2024 in Catapult’s Regulatory Round-up – October 2024 (catapult.org.uk).


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (19 novembre 2024). Food and Drug Administration (FDA) Revision of USP Chapter on Gene Therapy Medicinal Products (Catapult’s regulatory round-up – October 2024). ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12ps5


Vous aimerez aussi...

Laisser un commentaire

Votre adresse e-mail ne sera pas publiée. Les champs obligatoires sont indiqués avec *

This site uses Akismet to reduce spam. Learn how your comment data is processed.