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CDER announces a 4/13 Webinar entitled Biosimilars: A Decade of Experience and Future DirectionsStrategies for Improving Biosimila...[ Price : $8.95]
Baxter International issues an urgent safety communication on upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusi...[ Price : $8.95]
Ferring petitions FDA to require in vivo testing for ANDA and follow-on applications citing the companys Firmagon as the reference...[ Price : $8.95]
FDA classifies as Class 1 a recall of the E25Bio Covid-19 Direct Antigen Rapid Test because it has not been authorized, cleared, o...[ Price : $8.95]
FDA says it was able to approve a generic diclofenac sodium topical gel using an alternative method to determine bioequivalence.[ Price : $8.95]
Johns Hopkins researchers say a survey of U.S. adults shows people want much more transparency from FDA.[ Price : $8.95]
After retiring from FDA last year, controversial former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology direc...[ Price : $8.95]
FDA releases its proposed rule to change the Quality System Regulation by incorporating an international standard.