FDA issues a draft guidance encouraging drug developers to adopt new approach methodologies as part of a broader effort to reduce reliance on animal t...
Minutes from two February MDUFA 6 negotiating sessions show areas of agreement between FDA and industry and topics for which further discussion is nee...
FDA approves Johnson & Johnsons Icotyde as the first and only targeted oral peptide to treat plaque psoriasis in adults and some pediatric patients.
Public health experts call for sweeping reforms to improve FDAs transparency, arguing that longstanding gaps in disclosure persist despite recent prog...
FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater...
FDA issues an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet.
FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.
FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.
