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Attorney Anne Walsh says regulated companies may cite a recent Supreme Court decision when challenging the notion of judicial defe...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Male Breast Cancer: Developing Drugs for Treatment.[ Price : $8.95]
A recently posted Establishment Inspection Report involving AveXis Zlogensma, which is behind a data manipulation investigation, s...[ Price : $8.95]
CDER Office of Antimicrobial Products director Edward Cox leaves FDA to join Regeneron as regulatory affairs vice president.[ Price : $8.95]
FDA gives Staar Surgical IDE approval to begin a clinical trial for the EVO/EVO+ VISIAN Implantable Collamer Lens for myopia, and ...[ Price : $8.95]
FDA warns Indias CTX Lifesciences about CGMP deviations for active pharmaceutical ingredients.[ Price : $8.95]
FDA approves a Kyowa Kirin NDA for Nourianz (istradefylline) tablets as an add-on treatment for patients with Parkinsons disease e...[ Price : $8.95]
FDA releases the FDA-483 with 10 observations from an inspection at First Pharma Associates in Spokane, WA.