Notifying FDA of a Discontinuance or Interruption in Manufacturing

Guidance, Documents, Resources
1

Not directly mentioned Nitrosamines, but this should be on the radar for our regulatory affairs members…
FDA announced the availability draft guidance on

“Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act”

2 Likes