Federal Register notice: FDA seeks comments on an information collection revision entitled Prescription Drug User Fee Program.
FDA posts a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.
FDA clears a Hyperfine 510(k) for its advanced image reconstruction technology that uses deep learning to improve magnetic resonance imaging (MRI) on ...
FDA approves an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian cancer lesions.
An FDA advisory committee briefing document says Mercks oral antiviral molnupiravir is associated with a relative risk reduction of 52% in hospitaliz...
FDA Review posts the Federal register notices for the week ending 11/26/2021.
FDA Review posts product approval summaries for the week ending 11/26/2021.