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CDER Office of New Drugs director John Jenkins says his staff are worried about the outcomes from the addition of late-cycle meeti...[ Price : $8.95]
FDA approves a Sucampo Pharmaceuticals supplemental NDA for Rescula 0.15% for lowering intraocular pressure in patients with open-...[ Price : $8.95]
FDA releases the FDA-483 containing 14 inspection observations issued after an April inspection at Celltex Therapeutics.[ Price : $8.95]
FDA says the Natus Medical recall of the Olympic Cool-Cap System due to the potential for unexpected power failure and lack of coo...[ Price : $8.95]
FDA publishes a draft guidance to help drug sponsors minimize medication errors relating to drug product design.[ Price : $8.95]
Mylan calls on FDA to deny a Valeant petition asking that the agency require clinical endpoint studies for any ANDA for generic Zo...[ Price : $8.95]
FDA grants Milo Biotechnology an orphan drug designation for AAV1-FS344 for treating Becker and Duchenne muscular dystrophy.[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on an experimental study on...