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Clarke Pharmaceuticals Marketing Unapproved Drugs Online: FDA

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FDA warns Clarke Pharmaceuticals it is marketing unapproved and misbranded new drugs.

Allergans Botox OKd for Pediatric Bladder Condition

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FDA approves Allergans Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in certain...

House Democrats Seek Lift on Mifepristone Restriction

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A group of Democrats on the House Oversight Committee urge FDA to remove the in-person dispensing requirement for medical abortion...

Ava Wearable Fertility Tracker Cleared

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FDA clears an Ava 510(k) for its wearable Fertility Tracker to aid women in ovulation prediction and facilitating conception.

CGMP Violations at Allay Pharmaceuticals

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FDA warns Allay Pharmaceuticals about CGMP and other violations in its work as a contractor producing finished drugs.

Freeline Therapeutics Modifies Hemophilia B Therapy Plan

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Freeline Therapeutics says it has modified its clinical development plan for its adeno-associated virus vector-mediated gene thera...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Allay Pharmaceuticals and Ignacio J. Rodriguez.

FDA Monitoring Covid Ventilator Splitters

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FDA says it is monitoring clinical experience with ventilator splitters in situations in which no alternatives for invasive ventil...

Broaden Cancer Trial Eligibility: Advocates

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Two cancer advocacy groups publish recommendations on broadening eligibility criteria for cancer trials to make trials more access...

Adulterated ShangRao Hand Sanitizer

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FDA warns Chinas ShangRao Chunyu Technology Co. that its hand sanitizer that was detained at the U.S. border did not contain the l...