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Federal Register notice: FDA announces a 10/3 public meeting entitled Development of a List of Pre-DSHEA Dietary Ingredients.[ Price : $8.95]
Federal Register notice: FDA determines that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsul...[ Price : $8.95]
Federal Register notice: FDA determines that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 ...[ Price : $8.95]
AbbVie files an NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, indicated for...[ Price : $8.95]
Stakeholders praise FDA for enforcement discretion for manufacturers to meet Drug Supply Chain Security Act product identifier req...[ Price : $8.95]
FDA warns a Netherlands firm it is marketing a medical device in the U.S. without agency approval or clearance.[ Price : $8.95]
FDA places a clinical hold on two Cellectis Phase 1 studies involving cell therapy UCART123 in acute myeloid leukemia and in blast...[ Price : $8.95]
FDA warns Steiner Biotechnology about violations in its role as a sponsor-investigator of medical device clinical trials.