CDRH posts a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.
Attorney Sara Koblitz says a Federal Circuit Court of Appeals decision casts doubt on the long-established practice of generic drug companies carving ...
FDA issues a guidance on technical considerations for non-clinical assessment of medical devices containing nitinol.
Six drug companies submit technical comments on an FDA draft guidance on drug development for acute myeloid leukemia.
FDA says it will exercise enforcement discretion for some modifications to molecular influenza tests during the Covid-19 pandemic.
An FDA reinspection at a troubled Eli Lilly drug manufacturing plant in Branchburg, NJ finds additional GMP problems that could pose a hurdle for a pr...
Bayer files a supplemental NDA seeking to extend the duration of use for up to seven years for its intrauterine device Mirena (levonorgestrel-releasin...
FDA warns five dietary supplement manufacturers that they are producing products containing cesium chloride without meeting agency requirements for us...