Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act (Catapult’s regulatory round-up – february 2024)
The FDA has issued a draft guidance for industry entitled “Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” This draft guidance is intended to assist applicants and manufacturers in providing FDA timely notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that might help the Agency to prevent or mitigate shortages.
Published on the 5th of March 2024 in Catapult’s regulatory round-up for february 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act (Catapult’s regulatory round-up – february 2024). ELSIBI. Consulté le 10 décembre 2024 à l’adresse https://doi.org/10.58079/12mig
