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FDA DTC Push Cites GLP-1 Drugs in 4 Letters

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FDAs ongoing crack down on drug direct-to-consumer promotional activities results in three just-released Warning Letters to Eli Li...

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FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developi...

Dexcom Recalls G7 and ONE + Apps

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Dexcom recalls (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error.

aTyr Pharma Reports Mixed Results in Lung Trial

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aTyr Pharma reports mixed topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a chronic infla...