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FDA Strengthening Good Clinical Practice Oversight

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Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globaliz...

FDA Wants Botanical Drug Development Input

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FDA publishes a request for information on stakeholders views on ways to accelerate botanical drug development.

Study Connection Between Foreign Drug Manufacturing and Recalls

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The Senate Special Committee on Aging chairman and ranking member ask the Government Accountability Office to study and assess any...

Prevention Is the Best Counter to CRL Risk: Blog Post

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Consultants RMS suggests ways that companies can reduce the impact and risk of FDA complete response letters.

Food & Drug Legal Icon Peter Barton Hutt Passes Away at 91

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Former FDA chief counsel Peter Barton Hutt passes away at the age of 91.

Boston Scientific Recalls Spinal Cord Stimulator Leads

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Boston Scientific recalls all unused spinal cord stimulator Infinion CX Leads after determining that the lead body may experience ...

Early Alert: Draeger Breathing Circuit Issue

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CDRH issues an early alert based on a Draeger letter to customers recommending certain VentStar Resus Neo hoses (breathing circuit...

AbbVie Announces Positive Etentamig Data in Multiple Myeloma

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AbbVie announces positive topline results from the Phase 3 CERVINO study evaluating etentamig in patients with triple-class expose...

Cancer White Paper on Dosage Optimization

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A Friends of Cancer Research white paper recommends a new approach to support administered activity escalation and dosage optimiza...

Pediatric Research Policy and Procedure

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CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Ac...