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CDRH chief scientist William Maisel says the Center is working with medical device manufacturers to further development of innovat...[ Price : $8.95]
Stakeholders say an FDA draft guidance on the informed consent information sheet may lead to a document that is too complex for ma...[ Price : $8.95]
Sens. Harkin and Alexander say they will introduce legislation to add Ebola to the list of qualifying tropical diseases for an FDA...[ Price : $8.95]
FDAs Kansas City District Office warns Vitalab about many violations in its manufacturing and distribution of dietary supplements....[ Price : $8.95]
Industry and consumer groups say they differ on the value of an FDA draft guidance on communicating new risk information to health...[ Price : $8.95]
FDA plans a draft guidance on best practices for communications between agency reviewers and drug sponsors during product developm...[ Price : $8.95]
Wright Medical Groups BioMimetic subsidiary gets an Approvable Letter from FDA for its PMA on its Augment Bone Graft as an alterna...[ Price : $8.95]
Medical reviewers tell the FDA Cardiovascular and Renal Drugs Advisory Committee that Daiichi Sankyos Savaysa shows no advantages ...