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Alzheimers Drug Development Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment....

Biologic Adverse Event Reporting Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension on adverse experience reporting for licensed biologi...

Labeling for Animal Drugs Revision

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Federal Register proposed rule: FDA proposes to revise the requirements for the content and format of labeling for approved or con...

Windstone Medical Recalls Surgical Kits

[ Price : $8.95]

Windstone Medical Packaging recalls its Local Lower Extremity Pack, In-House Ocular Pack and Closure Kit in response to Nurse Assi...

FDA Rejects Viatris/Mapi Multiple Sclerosis Drug

[ Price : $8.95]

FDA sends Viatris/Mapi Pharma a complete response letter on the NDA for GA Depot 40 mg, a long-acting glatiramer acetate being inv...

Abbott Recalls HeartMate Touch System

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Abbott recalls its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start.

$500 Million Boost to FDA in Presidents Budget Proposal

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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 ...

Draft Guide on Developing Early Stage Alzheimers Drugs

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FDA posts a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment with a focus on the ultimate goal of ...

Docket Corrected on Covid Trial Guidance

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Federal Register notice: FDA corrects a 2/22 notice announcing the availability of a final guidance on assessing Covid19-related s...

Blood Products Advisory Panel Meeting

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Federal Register notice: FDA announces a 5/9 Blood Products Advisory Committee meeting on strategies to reduce the risk of transfu...