Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committ...
Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug ...
Drug companies and other stakeholders respond to an FDA draft guidance on using electronic health records and claims data in real-world data studies.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pharma Mars Zepzelca (lurbinectedin).
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FDA posts a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.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.