Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative information or they no longer reflects the agency...
FDA seeks comments from the pharmaceutical industry on its project to identify and prioritize pharmaceutical quality and chemistry and manufacturing a...
Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials.
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.
More than 65 scientific experts call on FDA to recommend that Covid-19 vaccine developers assess T-cells in addition to antibodies in vaccine trials.
Federal Register notice: FDA creates a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk Evaluation and Mitig...
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...
FDA approves commercial production at a new Kite CAR T-cell manufacturing facility in Maryland.