FDA opens a docket to receive feedback on exclusion of certain medical software functions from agency regulation under the 21st Century Cures Act.
FDA releases its latest batch of Warning Letters that includes Europharma Concepts, Jalco Cosmetics and Jilin Shulan Synthetic Pharmaceutical.
FDA Review posts the Federal Register notices for the week ending 5/25/2018.
FDA Review posts product approval summaries for the week ending 5/25/2018.
FDA approves a BioMarin Pharmaceutical NDA for Palynziq (pegvaliase-pqpz) for adults with phenylketonuria, a rare and serious genetic disease.
FDA clears a XableCath 510(k) for its XableCath abrasion tip support catheter for use by interventionalists in managing lesions and procedures in the ...
FDA grants Imagen a de novo marketing authorization for its OsteoDetect device, a computer-aided detection and diagnosis software designed to detect w...
FDA grants Krystal Biotech a fast track designation for KB103 for treating dystrophic epidermolysis bullosa.