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CGMP Violations at Custom Nutraceuticals

[ Price : $8.95]

FDA warns Custom Nutraceuticals about CGMP violations that adulterate its dietary supplements.

FDA Approves Cystadrops for Cystinosis Patients

[ Price : $8.95]

FDA approves Recordatis Cystadrops for reducing cystine crystal deposits in the cornea of the eye.

Dusa Paying $20.75 Million on FCA Allegations

[ Price : $8.95]

The Justice Department says Dusa will pay $20.75 million to resolve a whistleblowers charges that it induced doctors to file false...

FDA Allows Controversial Convalescent Plasma for Covid

[ Price : $8.95]

In a swirl of Trumpian controversy, FDA issues an emergency use authorization for Covid-19 convalescent plasma and its use in trea...

HelixBind Gets Breakthrough for Sepsis Test

[ Price : $8.95]

FDA awards HelixBind a breakthrough device designation for its RaPID/BSI, a direct-from-blood platform for identifying and charact...

Complete Response in Tricida Metabolic Acidosis NDA

[ Price : $8.95]

FDA issues Tricida a complete response letter on its NDA for veverimer, a non-absorbed, orally-administered polymer designed to tr...

Valencia Tech PMA for Bladder Electrical Stimulation

[ Price : $8.95]

Valencia Technologies files a PMA for its eCoin Peripheral Neurostimulator System for use in treating overactive bladder.

FDA Drug Study Reassures on Product Quality

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A new FDA study of 252 difficult-to-make prescription drugs finds that U.S.-marketed products consistently meet quality standards ...

New Drug Manufacturing Data Reporting Delayed: FDA

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FDA says it is delaying collection of new drug manufacturing data to help it track potential drug shortages until an electronic da...

Genentech Wins FDA Priority Review Voucher

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FDA issues a priority review voucher to Genentech for gaining approval of a rare pediatric disease product application Evrysdi (r...