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Federal Register notice: FDA seeks comments on an information collection extension for the guidance on dear doctor letters.[ Price : $8.95]
FDA approves AbbVies Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbust...[ Price : $8.95]
FDA approves an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis w...[ Price : $8.95]
FDA posts a draft guidance entitled Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment...[ Price : $8.95]
Federal Register proposed rule withdrawal: FDA announces the withdrawal of a proposed rule on Supplemental Applications Proposing ...[ Price : $8.95]
FDA posts a guidance entitled Manufacturing Site Change Supplements: Content and Submission.[ Price : $8.95]
FDA clears an EhmetDx 510(k) for its 3D CBCT (cone beam computed tomography) positioning software to be used in patient treatment ...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of nine ANDAs from multiple applicants.