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Comments Extended on Animal Drug Special Programs

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Federal Register notice: FDA extends the comment period on a 7/15 notice about a draft guidance #61 entitled Special Consideration...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Nartex Laboratorios Homeopaticos.

Pfizer/BioNTech Covid Vaccine 90% Effective Vaccine: Early Data

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Pfizer and BioNTech report data from an interim efficacy analysis showing that their Covid-19 vaccine is more than 90% effective i...

Panel Thumbs Down on Biogen Alzheimers Drug

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FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes not to recommend approval of Biogens Alzheimers drug adu...

Former FDA Head Kessler Co-chairs Biden Covid Advisors

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President-elect Joe Bidens transition team announces the formation of the Transition Covid-19 Advisory Board, which is co-chaired ...

CDER Report on Clinical Trials Global Participation

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CDER posts a report on Global Participation in Clinical Trials: 2015-2019 that summarizes the Centers Drug Trials Snapshot program...

Guidance on Drug Compounding Insanitary Conditions

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Federal Register notice: FDA releases a final guidance describing insanitary conditions at drug compounding facilities.

Guide on Assessing Drug User Fees

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FDA posts a final guidance on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.

Guidance on Improving Clinical Trial Diversity

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FDA publishes a final guidance on Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, Enrollment Practice...

Guide on Microneedling Product Regulatory Considerations

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FDA issues a final guidance discussing when a microneedling product is a device for regulatory purposes.