CDRH makes available a draft guidance on Power Morcellator containment systems clinical performance assessments.
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Federal Register notice: FDA makes available a draft guidance entitled Voluntary Consensus Standards Recognition Program for Regenerative Medicine The...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...