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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...

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...

Zealand Hypoglycemia NDA Denied FDA Approval

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FDA issues Zealand Pharma a complete response letter on its NDA for dasiglucagon and its use in preventing and treating hypoglycem...

Bayer Files NDA for Menopause Drug

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FDA accepts a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe hot flashes asso...

FDA Exempts Some from Supply Chain Security Act

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FDA grants exemptions to Drug Supply Chain Security Act eligible connected trading partners, pushing the implementation date for e...

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...

GSK Says Arexvy Protects Over Three RSV Seasons

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GSK says trial data show its Arexvy protects through three complete RSV seasons.