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FDA posts a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspec...[ Price : $8.95]
Federal Register notice: FDA seeks comments on a petition requesting exemption from the premarket notification requirements for po...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of an Impax ANDA for ursodiol capsules (XXX INSERT XXX)USP, 300 mg, due to agency ...[ Price : $8.95]
Former FDA Commissioner Scott Gottlieb joins FasterCures advisory board.[ Price : $8.95]
FDA clears a Zimmer Biomet Holdings 510(k) for the JuggerStitch meniscal repair device.[ 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FDA posts a draft guidance entitled Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment...[ Price : $8.95]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.