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Patent Listing in Orange Book Comments Extended

[ Price : $8.95]

Federal Register notice: FDA reopens the comment period for a 6/1 notice entitled Listing of Patent Information in the Orange Book...

Comments Sought on Covid-19 Guidances

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Federal Register notice: FDA makes available three guidance documents related to the Covid19 public health emergency that are subj...

Device Biotin Interference Testing Guidance

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FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.

Two Ex-Supplement Marketers Sentenced to Prison

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The northern Texas federal court sentences two former dietary supplement company executives to prison and orders two companies to ...

Pfizer CEO Predicts Covid Vaccine EUA Filing in November

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Pfizer CEO Albert Bourla says the company and its development partner BioNTech could file an emergency use authorization for their...

FDA Exploring Live Video Inspections During Covid

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FDA associate commissioner for regulatory affairs Judith McMeekin says the agency is evaluating whether it can use live or recorde...

Quality Management Maturity Pilot for APIs

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Federal Register notice: FDA announces a Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for forei...

CDRH Pioritized Guidance Listing for FY 2021

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CDRH posts a list of prioritized guidance documents that it intends to publish during fiscal year 2021.

Quality Management Pilot for Finished Drugs

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Federal Register notice: FDA announces its Quality Management Maturity for Finished Dosage Forms Pilot Program for domestic drug p...

CDRH Posts Videos of Device User Fee Accomplishments

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CDRH posts a series of videos highlighting the progress the Center has made to date with implementing the current medical device u...