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Biologics

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

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

Human Drugs

Panel Thumbs Down on Biogen Alzheimers Drug

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

Human Drugs

Former FDA Head Kessler Co-chairs Biden Covid Advisors

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

Human Drugs

CDER Report on Clinical Trials Global Participation

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

Federal Register

Guidance on Drug Compounding Insanitary Conditions

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

Human Drugs

Guide on Assessing Drug User Fees

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

Medical Devices

Guide on Microneedling Product Regulatory Considerations

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

Human Drugs

Guidance on Improving Clinical Trial Diversity

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

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Human Drugs

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 11/6/2020.