Some 30 GOP House members call on President Biden to take steps to alleviate a shortage of intravenous contrast agents.
FDA publishes the latest update for its list of off-patent, off-exclusivity drugs for which there are no approved generics.
Federal Register notice: FDA makes available a draft guidance entitled Voluntary Consensus Standards Recognition Program for Regenerative Medicine The...
Federal Register notice: FDA seeks comments on an information collection revision entitled Administrative Procedures for Clinical Laboratory Improveme...
Federal Register notice: FDA makes available a final guidance entitled Technical Performance Assessment of Quantitative Imaging in Radiological Device...
FDA releases the FDA-483 with six observations from an inspection at Phoenix, AZ-based Central Admixture Pharmacy Services.
FDA accepts for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage IB, II...
Five stakeholders recommend changes and clarifications to an FDA draft guidance on CAR-T cell product development.