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Threadbare Evidence OKd for Malaria Drug EUAs: Report

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A BuzzFeed review of internal FDA documents finds the agency granted emergency use authorization for chloroquine and hydroxychloro...

Comments Sought on Improving Orange Book

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Federal Register notice: FDA establishes a public docket to solicit comments on the agencys Approved Drug Products With Therapeuti...

Medtronic Recalls Brain Stimulation Software

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Medtronic recalls the auto-registration feature of its StealthStation Deep Brain Stimulation Software due to inaccuracies caused b...

FDA Evaluating Covid Changes to Make Some Permanent

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FDA commissioner Stephen Hahn says permanent procedural and policy changes will flow from the agency's Covid-19 response.

Comments Sought on Rare Disease Trial Network

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Federal Register notice: FDA establishes a docket to obtain information and comments from stakeholders about establishing a rare d...

Orange Book Questions and Answers Guide

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Federal Register notice: FDA makes available a draft guidance entitled Orange Book Questions and Answers.

Comments Sought on Patent Listing in Orange Book

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Federal Register notice: FDA creates a docket to solicit comments on the listing of patent information in the agencys Approved Dru...

Court Orders Sundial Herbal to Stop Distribution

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A New York federal judge orders Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until it co...

Safety Alert on Epinephrine Auto-Injector

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An FDA safety alert asks patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impa...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company LifeHealth Science.