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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Banco Vida, Custom Nutraceuticals and Wintac Limited.

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...

Rule Removes Vaccine Mycoplasma Testing

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Federal Register notice: FDA issues a final rule to remove the specified test for detecting the presence of Mycoplasma for live vi...

FDA Allows Controversial Convalescent Plasma for Covid

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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

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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

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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

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

Study Data Tabulation Model Notice Corrected

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Federal Register notice: FDA corrects a notice that appeared in the 7/7 Federal Register that discussed version 1.7 of the Clinica...