The CDER Office of Pharmaceutical Quality publishes a white paper making the economic case for quality management practices.
FDA issues a question-and-answer guidance on the development of certain antibacterial therapies.
FDA approves a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylketonuria, a rare inhe...
FDA posts the user fee rates for fiscal year 2026 for prescription drugs and biologics, biosimilar, medical devices and generic drugs.
FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medical device specificati...
FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.
Recognify Life Sciences says its Phase 2b trial of inidascamine, a drug candidate for treating cognitive impairment associated with schizophrenia, did...
After being criticized for attempting to bypass a formal advisory committee review of warnings associated with hormone replacement therapies, FDA anno...
