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FDA publishes a draft guidance to help sponsors of some products regulated by CDER and CBER perform nonclinical safety evaluations...[ Price : $8.95]
Former FDA attorney William McConagha moves from Sidley Austin to Skadden, Arps, Slate, Meagher & Flom as health care litigation a...[ Price : $8.95]
Federal Register notice: FDA announces a 4/21 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supp...[ Price : $8.95]
Federal Register notice: FDA announces a 4/23 Medical Imaging Drugs Advisory Committee meeting to review an Avid Radiopharmaceutic...[ Price : $8.95]
FDA denies a petition asking it to require compliance with a guidance and taken enforcement action against non-compliant manufactu...[ Price : $8.95]
FDA issues Merck a complete response letter on a supplemental BLA seeking to update the dosing frequency for Keytruda (pembrolizum...[ Price : $8.95]
ResMed recalls its Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure.[ Price : $8.95]
FDA issues an Establishment Inspection Report to Aurobindo Pharma for its Pashamylaram Unit 4 injectable manufacturing facility.