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FDA Plans Pediatric Acetaminophen Safety Order

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While denying a Parenteral Technologies petition to force a change in pediatric acetaminophen directions for use, FDA says it is p...

Medical Device Company Sentenced to Pay $42 Million

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The Justice Department says Magellan Diagnostics has been ordered to pay $42 million in fines, forfeitures, and compensation after...

FDA Approves Genentechs Itovebi Breast Cancer Drug

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FDA approves Genentechs Itovebi to be used with two other drugs to treat some breast cancers identified through a diagnostic test....

Implantable Bladder Stimulator Study Approved

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FDA approves an IDE for Iota Biosciences to conduct a feasibility study of its investigational implantable device designed to deli...

Part 11 Final Guide has Broader Applicability: Attorneys

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Attorneys at Hogan Lovells say (XXX DELETE s XXX)that a final guidance on electronic records and systems used in clinical trials i...

Teva Pays $450 Million to Settle Kickback Cases

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Teva Pharmaceuticals agrees to pay $450 million to resolve two civil cases that allege the company violated the Anti-Kickback Stat...

Do More to Prevent DSCSA Disruptions: Congress

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Some 21 House Democrats and Republicans ask FDA to take more steps to prevent drug shortages as the Drug Supply Chain Security Act...

Neuvivo Files NDA for Lou Gehrigs Therapy

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Neuvivo files an NDA for NP001 (sodium chlorite infusion) for treating amyotrophic lateral sclerosis (also known as Lou Gehrigs di...

FDA New Alternative Methods Office Needed: Report

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An FDA Science Advisory Board subcommittee calls on the agency to create a centralized office to coordinate work on New Alternativ...

IDE OKd for Robotic Prostate Cancer Surgery

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FDA approves a Procept BioRobotics IDE for a clinical trial comparing its Aquablation therapy to radical prostatectomy in men with...