The new year brings ongoing challenges for FDA, 60% of whose employees are now working without pay because of the partial government shutdown, and the...
FDA posts a draft guidance entitled Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment.
Federal Register proposed rule withdrawal: FDA announces the withdrawal of a proposed rule on Supplemental Applications Proposing Labeling Changes for...
FDA posts a guidance entitled Manufacturing Site Change Supplements: Content and Submission.
FDA clears an EhmetDx 510(k) for its 3D CBCT (cone beam computed tomography) positioning software to be used in patient treatment at the McLaren Proto...
Federal Register notice: FDA withdraws approval of nine ANDAs from multiple applicants.
Federal Register notice: FDA makes available a final guidance entitled Data Integrity and Compliance With Drug CGMP: Questions and Answers.
FDA approves a Celltrion BLA for Herzuma (trastuzumab-pkrb) as a biosimilar to Genentechs Herceptin (trastuzumab) for patients with HER2-overexpressin...