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CDER researchers say they are developing a non-inferiority paradigm to assess exposure-response similarity between pediatric and a...[ Price : $8.95]
The Sedgwick Recall Index says medical device recalls soared in the second quarter of 2022, while drug recalls remained level with...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Hydrogen Peroxide- Based Contact Lens Care Products: Consum...[ Price : $8.95]
FDA lifts a partial clinical hold on the Curis TakeAim Lymphoma study of emavusertib.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Replacement Reagent and Instrument Family Policy for In Vit...[ Price : $8.95]
Federal Register notice: FDA announces a 10/6 Vaccines and Related Biological Products Advisory Committee meeting to discuss the v...[ Price : $8.95]
FDA approves a Bayer sNDA for its Mirena intrauterine system for extended use of up to eight years as a contraceptive.[ Price : $8.95]
FDA accepts for priority review an Astellas Pharma NDA for fezolinetant, a nonhormonal compound for treating moderate to severe va...