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The CDER Office of Pharmaceutical Quality publishes a white paper making the economic case for quality management practices.[ Price : $8.95]
FDA issues a question-and-answer guidance on the development of certain antibacterial therapies.[ Price : $8.95]
FDA approves a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylke...[ Price : $8.95]
FDA posts the user fee rates for fiscal year 2026 for prescription drugs and biologics, biosimilar, medical devices and generic dr...[ Price : $8.95]
FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medica...[ Price : $8.95]
FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.[ Price : $8.95]
Recognify Life Sciences says its Phase 2b trial of inidascamine, a drug candidate for treating cognitive impairment associated wit...[ Price : $8.95]
After being criticized for attempting to bypass a formal advisory committee review of warnings associated with hormone replacement...