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Human Drugs

Study Connection Between Foreign Drug Manufacturing and Recalls

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

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Human Drugs

Prevention Is the Best Counter to CRL Risk: Blog Post

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

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FDA General

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

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

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Medical Devices

Boston Scientific Recalls Spinal Cord Stimulator Leads

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

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Medical Devices

Early Alert: Draeger Breathing Circuit Issue

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

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Human Drugs

AbbVie Announces Positive Etentamig Data in Multiple Myeloma

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

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Human Drugs

Shoolin Pharma Insanitary Conditions, CGMP Issues

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

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Human Drugs

Boxed Warning for Injectafer on Low Phosphate Levels

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

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Biologics

uniQure Files BLA for Huntingtons Gene Therapy

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

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Human Drugs

Early Alert: Convenience Kit Issue from AVID Medical

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