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Public Meeting on Generic Drug User Fees

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Federal Register notice: FDA announces an 11/16 public meeting to discuss proposed recommendations for the reauthorization of the ...

HHS Abandons Trump Administration SUNSET Rule

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Federal Register notice: Health and Human Services proposes to withdraw a final rule entitled Securing Updated and Necessary Statu...

FDA Portal for Annual Drug Manufacturing Reporting

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FDA announces the availability of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biol...

Zimmer Biomet Recalls Rosa One Brain App

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Zimmer Biomet recalls its Rosa One 3.1 Brain Application, a robotic platform that helps neurosurgeons with positioning medical ins...

FDA Listing on Device EUAs During Covid

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Federal Register notice: FDA announces a periodic listing of Emergency Use Authorizations for certain medical devices related to t...

4 Information Collections Approved by OMB

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Federal Register notice: FDA posts a list of information collections that have been approved by OMB.

Enzyvant Wins Priority Review Voucher

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Federal Register notice: FDA issues a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified ...

HHS, Purdue Differ on Buprenorphine

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As HHS suggests increasing access to buprenorphine to treat opioid addiction, manufacturer Purdue Pharma emphasizes its addiction ...

OPDP to Study Targeted Mechanism of Action in Ads

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The CDER Office of Prescription Drug Promotion says it will study how consumers and healthcare professionals react to promotional ...

Millions of J&J Covid Doses in Storage: Report

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Millions of J&J Covid vaccine doses are reported to be sitting in the Emergent facility in Baltimore waiting for FDA to authorize ...