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Are FDA Advisory Committees Doomed?

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FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of ad...

AstraZeneca Fasenra Trial Misses in COPD

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AstraZeneca reports that data from a Phase 3 trial of Fasenra (benralizumab) did not achieve the primary endpoint in patients with...

Concerning DTC Ad Misbrands Hizentra: FDA

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FDA warns CSL Behring that a direct-to-consumer TV spot for its Hizentra overstates the drugs effectiveness and minimizes its risk...

Multiple Violations in Illegal Marketing of SeniorLife.AI

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FDA warns Bellevue, WA-based SeniorLife.AI about multiple violations in its illegal marketing of an artificial intelligence-based ...

Alert on Medline Kits with Medtronic Heart Catheter

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FDA issues an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Cathet...

CGMP Violations in Somerset Therapeutics Inspection

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FDA warns Indias Somerset Therapeutics about CGMP and Field Alert Reporting violations in its production of finished drugs.

China Speeding Drug Approvals: CIRS Briefing

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A Center for Innovation in Regulatory Science briefing paper stresses Chinas faster drug approvals and the need for sponsors to ma...

40 DTC Untitled Letters Posted by FDA

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FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it ...

Guide on Developing Drugs to Treat Erosive Esophagitis

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FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developi...

4 Observations in Lupin Inspection

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FDA releases the form FDA-483 with four observations from an inspection at the Lupin drug manufacturing facility in Madhya Pradesh...