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Former FDA deputy commissioner Mary Pendergast warns that CDER is making stealth comparative effectiveness decisions on standard N...[ Price : $8.95]
FDA says it will consider information presented by an industry working group on opioid REMS and take its recommendations to an adv...[ Price : $8.95]
An FDA complete response letter on Endos Aveed testosterone injection asks for more adverse event information and a revised REMS.[ Price : $8.95]
Public Citizen again calls on FDA to immediately pull Abbotts Meridia from the U.S. market.[ Price : $8.95]
Federal Register Notice: FDA determines that Mesantoin (mephenytoin) tablets, 100 mg, were not withdrawn for reasons of safety or ...[ Price : $8.95]
FDA issues a draft guidance with recommendations to facilitate developing immune assays for assessing therapeutic protein immunoge...[ Price : $8.95]
FDA posts information for healthcare professionals on birth defects associated with exposure to valproate sodium during pregnancy.[ Price : $8.95]
Washington Legal Foundation and three patient groups say they support Allergans challenge to FDA regulations preventing it from sh...