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FDA publishes a draft guidance to help drug sponsors minimize medication errors relating to drug product design.[ Price : $8.95]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...[ Price : $8.95]
FDA publishes a draft guidance to help manufacturers design and develop home use medical devices that minimize their unique risks.[ Price : $8.95]
FDA grants Diffusion Pharmaceuticals an Orphan Drug designation for trans sodium crocetinate and its use in treating metastatic br...[ Price : $8.95]
FDAs Seattle District Office warns Parks Medical Electronics about multiple Quality System violations at its facility manufacturin...[ Price : $8.95]
CDER associate director for biosimilars Leah Christl says biosimilar product developers have essentially ignored FDAs abbreviated ...