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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]
Federal Register notice: FDA makes available a final guidance entitled The Special 510(k) Program.[ Price : $8.95]
An FDA safety alert says that an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has n...[ Price : $8.95]
FDA says it will develop bioanalytical best practices for biosimilar biological product development.