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Stakeholders call on FDA to make significant changes to a draft cyber security guidance document for medical devices.[ Price : $8.95]
The FDA Drug Safety Oversight Board discusses medical product safety objectives being sought by the agency through its work with H...[ Price : $8.95]
An Ohio federal judge approves a permanent injunction sought by FDA against Shamrock Medical Solutions Group for drug GMP and labe...[ Price : $8.95]
FDA accepts for review an NDA from AstraZeneca subsidiary Omthera Pharmaceuticals for the investigational drug Epanova to treat se...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Patient Counseling Information Section of Labeling for Human Prescription ...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Electronic Source Data in Clinical Investigations.[ Price : $8.95]
Novo Nordisk and BIO ask FDA to spell out a drug detention policy that doesnt keep safe medicines from people who need them.[ Price : $8.95]
Researchers say that 60% of Rx drug TV ads and 80% of OTC drug TV ads contain false or potentially misleading statements.