Federal Register notice: FDA makes available a final guidance entitled Heparin-Containing Medical Devices and Combination Products: Recommendations fo...
Federal Register notice: FDA makes available a final guidance entitled Grandfathering Policy for Packages and Homogenous Cases of Product Without a Pr...
FDA releases an ADMA Biologics FDA-483 with eight inspection observations.
FDA says its review of deaths and adverse events associated with Acadias Nuplazid did not show any new or unexpected safety findings.
FDA awards five grants for improvements to continuous manufacturing of biological products.
Getinge begins a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps due to a potential interruption or inability to ...
FDA disputes findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions, such as rheumatoid ...
FDA releases an FDA-483 with 11 observations from an inspection at Chinas Zhejiang Huahai Pharmaceutical Co.