Federal Register notice: FDA sends to OMB an information collection extension on adverse experience reporting for licensed biologics.
Federal Register proposed rule: FDA proposes to revise the requirements for the content and format of labeling for approved or conditionally approved ...
Windstone Medical Packaging recalls its Local Lower Extremity Pack, In-House Ocular Pack and Closure Kit in response to Nurse Assists 2023 ongoing rec...
FDA sends Viatris/Mapi Pharma a complete response letter on the NDA for GA Depot 40 mg, a long-acting glatiramer acetate being investigated as a once-...
Abbott recalls its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start.
President Biden seeks a $500 million boost in FDAs spending in fiscal year 2025, which is 7.4% more than the current $6.7 billion spending level in FY...
FDA posts a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment with a focus on the ultimate goal of delaying or halting/...
Federal Register notice: FDA corrects a 2/22 notice announcing the availability of a final guidance on assessing Covid19-related symptoms in outpatien...
