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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...

Shoolin Pharma Insanitary Conditions, CGMP Issues

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FDA warns Indias Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with sign...

Boxed Warning for Injectafer on Low Phosphate Levels

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FDA orders a Boxed Warning for American Regents Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophos...

uniQure Files BLA for Huntingtons Gene Therapy

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Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an i...

Early Alert: Convenience Kit Issue from AVID Medical

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CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain ki...

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...