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GOP Senators Urge Increase in Foreign Inspections

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Nine Republican senators press FDA to increase its foreign inspections of medical product manufacturing facilities.

Amgen Files Priority BLA for Lung Cancer

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FDA accepts for priority review an Amgen BLA for tarlatamab for treating certain adult patients with advanced small cell lung canc...

AdvaMed Faults FDA on Safety 510(k) Guidances

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AdvaMed faults FDA for not approving an extension to the comment deadline on three 510(k) guidances issued in September concerning...

Syndax Pharma Filing NDA for Revumenib

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Syndax Pharmaceuticals plans an NDA submission by year end for revumenib, a first-in-class menin inhibitor for treating patients w...

Patient Experience Data Stakeholder Comments

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Federal Register notice: FDA posts a summary of the comments received for the Methodological Challenges Related to Patient Experie...

Supreme Court Agrees to Hear Mifepristone Case

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The U.S. Supreme Court agrees to hear arguments in an appeal of the 5th Circuit Court of Appeals decision that places restrictions...

New Genetic Metabolic Disease Treatment A/C

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FDA says it is creating a nine-member Genetic Metabolic Diseases Advisory Committee.

Strengthen Botox Safety Warning: Public Citizen

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Public Citizen calls on FDA to strengthen the Botox Boxed Warning to highlight the risk of systemic iatrogenic botulism and relate...

Advanced Manufacturing Technologies Guidance

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FDA publishes a draft guidance on the Advanced Manufacturing Technologies Designation Program and its benefits for drug developmen...

Dolor Tech Settles Over Migraine Device

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Utah-based medical device company Dolor Technologies settles False Claims Act charges with the federal government over a device it...