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FDA approves an Edgemont Pharmaceutical NDA for fluoxetine tablets 60 mg, the active ingredient in Eli Lilly's Prozac.[ Price : $8.95]
FDAs Seattle District Office warns X-Ray Support, Inc. about Quality System and registration violations in its manufacturing of de...[ Price : $8.95]
FDA issues a guidance on content and format of specific labeling sections for human Rx drug products and biologicals.[ Price : $8.95]
FDA issues a guidance to help drug manufacturers incorporate physical-chemical identifiers into solid oral dosage forms.[ Price : $8.95]
The European Commission proposes revising requirements on information that drug companies can give to the public on Rx medicines.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on appeals of science-based decisions at the Center for ...[ Price : $8.95]
In its latest batch of Warning Letters FDA cites Botanic Oil Innovations and X-Ray Support.[ Price : $8.95]
FDA maintains a clinical hold on an Insmed Phase 3clinical trial for Arikace (liposomal amikacin for inhalation) in cystic fibrosi...