The Federal Trade Commission urges FDA to abandon its proposed naming convention for subsets of biologic products.
Federal Register notice: FDA makes available a draft guidance entitled Submitting Documents Using Real-World Data and Real-World Evidence to FDA for D...
Federal Register notice: FDA makes available a draft guidance entitled Postapproval Pregnancy Safety Studies that provides recommendations on how to d...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Lactation Studies: Considerations for Study Design.
FDA publishes a guidance with recommendations for designing and conducting maximal usage trials for topically applied active ingredients intended for ...
FDA publishes a guidance to help potential drug product applicants determine whether to submit an ANDA or a 505(b)(2) application.
FDA grants de novo marketing clearance to KCI for Prevena Incision Management System, a negative pressure medical device indicated to aid in reducing ...
FDA grants Farapulse a breakthrough device designation for its Farapulse Pulsed Field Ablation System and its use in treating drug-refractory, recurre...