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2 Draft DSCSA Guidances Out

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FDA publishes two draft guidances revising previous Drug Supply Chain Security Act guidances.

FDA Warns 5 Kratom Distributors

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FDA warns five companies that they are illegally distributing kratom products that are unapproved new drugs.

FDA Lifts Vertex Stem Cell Therapy Clinical Hold

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FDA lifts its clinical hold on Vertex Pharmaceuticals VX-880 stem cell therapy for type 1 diabetes.

No Zyesami EUA: FDA

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FDA declines to approve an emergency use authorization for NRx Pharmaceuticals Zyesami in some critical Covid-19 patients.

FDA Advisors to Reconsider Amylyx ALS Drug

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The FDA Peripheral and Central Nervous System Drugs Advisory Committee meets on 9/7 to consider new information from Amylyx on its...

FDA Posts eMDR Enhancements

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FDA lists enhancements to the CDRH electronic medical device reporting system and sets a schedule for future changes.

Patient-focused Drug Guide Docket Correction

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Federal Register notice: FDA corrects the docket number associated with a 6/30 notice on a draft guidance entitled Patient-Focused...

Genetic Evidence Supports Many FDA Drug Approvals: Study

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UK researchers say genetic evidence supports two-thirds of drugs FDA approved in 2021.

Federal Register Notices Week of July 4

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FDA Webview posts the Federal Register notices that published during the week of our annual Fourth of July (Independence Day) holi...

Bill Introduced to Ban Misleading DTC Ads

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U.S. Rep. Abigail Spanberger (D-VA) introduces the Banning Misleading Drug Ads Act that is intended to prevent manufacturers from ...