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ACRA McMeekin announces FDA's first FDA Inspectional Affairs Council meeting this week to discuss optimizing agency inspections on...[ Price : $8.95]
CNN reports that Janet Woodcock is no longer the front-runner to be named FDA commissioner due to concerns voiced by some Senate D...[ Price : $8.95]
Three top CDER officials say their decision to grant accelerated approval to Biogens Aduhelm was consistent with the requirements ...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion plans to study how healthcare professionals respond to prescription drug exhibit bo...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Eligibility Criteria for Expanded Conditional Approval of N...[ Price : $8.95]
FDA clears an EnsoData 510(k) for new capabilities and enhancements to its EnsoSleep product, an artificial intelligence-assisted ...[ Price : $8.95]
Innoveix Pharmaceuticals recalls several lots of sterile compounded drug products due to a lack of sterility assurance that was de...[ Price : $8.95]
Federal Register notice: FDA announces that it has issued a priority review voucher to Mallinckrodts Stratatech unit after approvi...