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Federal Register notice: FDA makes available a draft guidance entitled Male Breast Cancer: Developing Drugs for Treatment.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