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Ex-CDC Chief Says FDA Facing Similar Political Pressure

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Former CDC director Susan Monarez says FDA and other health agencies are facing similar political pressure that she experienced to...

DoJ Charges Man in Misbranded Rx Drug Case

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The Department of Justice charges David Ralph Webber with smuggling and selling misbranded prescription drugs marketed as sexual e...

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...

Becton Dickinson Expands Alaris Pump Recall

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Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing po...

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...