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Commenters suggest ways to improve an FDA draft informed consent information sheet guidance.[ Price : $8.95]
Reps. Israel and Bishop says an FDA proposed rule changing generic drug labels could severely harm the industry.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Custom Device Exemption.[ Price : $8.95]
A U.S. Navy contractor to FDA who studied quality of life issues in LASIK patients publishes an article saying unreasonable expect...[ Price : $8.95]
Shire Pharmaceuticals agrees to pay the U.S. government $56.5 million to resolve civil allegations that it violated the False Clai...[ Price : $8.95]
The International Consortium for Innovation and Quality calls on FDA to add more detail and clarity to a draft guidance on clinica...[ Price : $8.95]
Federal Register Notice: FDA is making available a draft guidance on harmonizing the data recommendations associated with in vivo ...[ Price : $8.95]
FDA clears an expanded indication for Nova Biomedicals StatStrip glucose hospital meter system for use with critically ill patient...