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Public Citizen petitions FDA for a Boxed Warning on Plavix labeling about risk of potentially fatal bleeding after more than 12 mo...[ Price : $8.95]
CHPA asks for an FDA statement of enforcement discretion allowing companies to label childrens OTC acetaminophen products with dos...[ Price : $8.95]
FDA approves marketing of bioMerieux Vitek MS for mass spectrometry identification of 193 bacteria and yeasts.[ Price : $8.95]
Nuvo Research files a lawsuit against Mallinckrodt asserting that the company has breached its contractual obligations under a 200...[ Price : $8.95]
CDRH Office of Science and Engineering Laboratories director Steven Pollack blogs about his organizations use of 3-D printing to f...[ Price : $8.95]
FDA clears a Reverse Medical 510(k) for the MVP Micro Vascular Plug system for peripheral artery embolization.[ Price : $8.95]
FDA clears a Novo Nordisk 510(k) for its insulin delivery device NovoPen Echo.[ Price : $8.95]
CDER issues a MAPP spelling out roles to be played in a response coordinated by the Office of Generic Drugs to ANDA suitability pe...