[ Price : $8.95]
FDA issues a draft guidance encouraging drug developers to adopt new approach methodologies as part of a broader effort to reduce ...[ Price : $8.95]
Minutes from two February MDUFA 6 negotiating sessions show areas of agreement between FDA and industry and topics for which furth...[ Price : $8.95]
FDA approves Johnson & Johnsons Icotyde as the first and only targeted oral peptide to treat plaque psoriasis in adults and some p...[ Price : $8.95]
Public health experts call for sweeping reforms to improve FDAs transparency, arguing that longstanding gaps in disclosure persist...[ Price : $8.95]
FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and med...[ Price : $8.95]
FDA issues an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet.[ Price : $8.95]
FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.[ Price : $8.95]
FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.