Federal Register notice: FDA announces a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management A...
FDA asks manufacturers of Zantac and Axid to test for NDMA impurities and not release lots that are above the acceptable daily limit.
Federal Register notice: FDA is seeking comments on an information collection revision for Dietary Supplements good manufacturing practices.
Federal Register notice: FDA seeks comments on an information collection extension for Human Cells, Tissues, and Cellular and Tissue-Based Products: E...
ViiV Healthcare files an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection.
Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representatives to s...
An International Consortium of Investigative Journalists report finds that unlike CDER, CDRH refuses to make public MAUDE data on patients sex, age, a...
FDA authorizes Roche to market its cobas vivoDX MRSA diagnostic test that speeds the detection of MRSA using new technology.