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Rep. Erik Paulsen complains to President Obama about pending 510(k) approval pathway changes being considered by FDA.[ Price : $8.95]
FDA raises issues about an industry performance proposal as part of MDUFA 3 reauthorization talks.[ Price : $8.95]
FDA warns Zhejang Casing of CGMP problems at its drug facility in China.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Angiodynamics, Confidence, Nanjing Maohai Biotech, Velocity Pharma, and Zhejiang...[ Price : $8.95]
FDA approves a Perrigo ANDA for ketoconazole foam, 2%, a generic version of Stiefel Labs Extina Foam.[ Price : $8.95]
Federal Register Final rule: FDA changes the name and function of the Anesthetic and Life Support Drugs Advisory Committee.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on labeling of tablets that have been scored.[ Price : $8.95]
Aeterna Zentaris says positive Phase 3 trial results for its oral diagnostic test for adult growth hormone deficiency will be revi...