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FDA solicits comments on a draft guidance to update and clarify the Special 510(k) program for some medical devices.[ Price : $8.95]
FDA announces new and expanded research efforts into compounded drugs.[ Price : $8.95]
Federal Register notice: FDA reopens the comment period related to two draft guidance documents on coronary drug-eluting stents.[ Price : $8.95]
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency in writing ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Insanitary Conditions at Compounding Facilities.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Compounding and Repackaging of Radiopharmaceuticals by Outs...[ Price : $8.95]
Federal Register notice: FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for...[ Price : $8.95]
Federal Register notice: FDA announces an 11/2 joint advisory committee meeting to review a Sage Therapeutics NDA for its proposed...