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FDA posts a draft guidance entitled Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.[ Price : $8.95]
FDA investigators cite five GMP issues during a September inspection at Modernas primary facility in Norwood, MA, according to a R...[ Price : $8.95]
Federal Register notice: FDA seeks nominations for voting members to serve on CDRHs Medical Devices Advisory Committee device pane...[ Price : $8.95]
FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medic...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance for industry entitled Inspection of Injectable Products for Visible ...[ Price : $8.95]
Federal Register notice: FDA classifies the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 ...[ Price : $8.95]
CDER Office of Compliance director Donald Ashley says the Center has ramped up its enforcement of ClinicalTrials.gov compliance, s...[ Price : $8.95]
FDA researchers work with industry and clinicians to determine the best way to apply modeling information to improve pediatric dos...