FDA publishes a guidance to help manufacturers of certain specified human cells, tissues, and cellular and tissue-based products report deviations.
Federal Register notice: FDA announces a 10/3 public meeting entitled Development of a List of Pre-DSHEA Dietary Ingredients.
Federal Register notice: FDA determines that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsules, 60 milligrams (m...
Federal Register notice: FDA determines that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 mg, were not withdra...
AbbVie files an NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, indicated for managing endometrio...
Stakeholders praise FDA for enforcement discretion for manufacturers to meet Drug Supply Chain Security Act product identifier requirements.
Six health groups ask FDA to remove ultra-high dosage unit opioid analgesics from the market because their harms outweigh the benefit of taking fewer ...
FDA publishes a guidance listing items to consider when developing and designing interoperable medical devices.