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FDA says it is giving a two-week grace period for generic drug manufacturing facility self-identification required under the Gener...[ Price : $8.95]
FDA approves a Sucampo Pharmaceuticals supplemental NDA that removes pregnancy warnings and precautions related to Amitiza (lubipr...[ Price : $8.95]
Jazz Pharmaceuticals begins a clinical trial involving asparaginase Erwinia chrysanthemi administered intravenously as an alternat...[ Price : $8.95]
A Boston newspaper reports that New England Compounding Center is the target of a federal grand jury investigation into its role a...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on investigational device exemptions reports and records...[ Price : $8.95]
Federal Register Notice: FDA seeks comment on the collection of information for its antiparasitic drug and resistance survey.[ Price : $8.95]
A new CDER guidance summarizes the IND process for positron emission tomography drugs, and provides advice on investigational PET ...[ Price : $8.95]
FDA announces the creation of the first public-private partnership intended to promote medical device regulatory science.