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Alchymars ICM SM Inspection Issues

[ Price : $8.95]

FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.

CGMP Issues at Japans Sato Pharmaceutical Co.

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FDA warns Japans Sato Pharmaceutical Co. about CGMP violations in its production of finished over-the-counter drugs.

U.S. Urges High Court Rejection of Compounding Case

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The U.S. government urges the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whe...

Outlook Wins FDA Appeal After 3 Complete Responses

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Outlook Therapeutics wins an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path towa...

Intas Pharma Facility in India Hit With Form-483

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FDA investigators cite major quality control and data integrity concerns at an Indian manufacturing facility operated by Intas Pha...

Dyne Files BLA for Duchenne Muscular Dystrophy Therapy

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Dyne Therapeutics submits a BLA that seeks accelerated approval for its experimental Duchenne muscular dystrophy therapy z-rostudi...

Dont Expect a New FDA Commissioner Soon: Grossman Column

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FDA Matters founder Steven Grossman explains why he thinks it will take the Trump administration at least until the end of the yea...

Senator Concerned About Cybersecurity and Chinese Devices

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Senator Tom Cotton (R-AR) urges FDA and government cybersecurity officials to review Chinese-made medical devices cleared before u...

Seismic Loper Bright Impact Not Yet Seen: Attorneys

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A Yale Journal on Regulation article from the Yale Law School Solomon Center for Health Law & Policy examines how the Supreme Cour...

Early Alert on Abiomed Heart Pump Controller Software Problem

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FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by ...