FDA recommends placing 7-hydroxymitragynine (7-OH) a highly concentrated, synthetic byproduct of the kratom plant under the Controlled Substances Act...
FDA warns Indias Shiva Analyticals Private Limited about CGMP violations in its work as a contract testing laboratory.
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.
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...
