Two Ropes & Gray attorneys highlight things learned from an FDA draft guidance on how FDA will regulate multiple function medical devices.
FDA reminds healthcare professionals working in surgical settings of the risk of surgical fires that can injure patients.
FDA issues a guidance to assist in developing drugs to treat complicated intra-abdominal infections.
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.