Attorney Jeffrey Gibbs outlines provisions advanced by FDA as a new approach to regulating in vitro diagnostics and laboratory-developed tests.
FDA warns Chinas Yicheng Goto Pharmaceuticals about significant deviations of current good manufacturing practice regulations for active pharmaceutica...
FDA cautions registrants of two Web sites promoting iCare HIV tests that the tests are not approved for sale in the U.S.
FDA releases its latest batch of Warning Letters that include Apotex Research Private Ltd., Paramesh Banerji Life Sciences, Signature Formulations, JT...
Federal Register notice: FDA makes available a draft guidance entitled Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Developmen...
Federal Register notice: FDA announces a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to identify wh...
FDA grants de novo marketing for Natural Cycles Nordics Natural Cycles mobile medical application that can be used as a method of contraception to pre...
Hologics Cynosure division suspends marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heating vaginal tissue, ...