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An unidentified petitioner asks FDA not to approve an NDA for United Therapeutics Tyvaso DPI without trial results showing it is s...[ Price : $8.95]
Acting FDA commissioner Janet Woodcock defends the agencys Aduhelm approval but says the process could have been handled less cont...[ Price : $8.95]
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 ...