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Califf on Tweaking Accelerated Approvals, No Big Revamp

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FDA commissioner Robert Califf says a total revamp of the drug accelerated approval program is not needed to answer criticism foll...

Whole-of-Governments Approach to Illicit Medical Products

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FDA says it is working with the Organization of Economic Cooperation and Development on a whole-of-governments approach to fightin...

FDA to Study Breast Implant Risk Perception

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FDA says it is funding a study of patient perceptions of the risk of a specific cancer associated with textured breast implants.

Panel Backs Moderna Covid Vaccine in Children

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An FDA advisory committee votes unanimously (22 to 0) to recommend the agency grant Moderna an emergency use authorization for its...

ICH Draft Quality Risk Management Guidance

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FDA publishes a draft International Council for Harmonization guidance on quality risk management with no new regulatory expectati...

Notice Corrected on Donor Eligibility Requirements

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Federal Register notice: FDA corrects a 5/24 notice on a draft guidance being made available entitled "Blood Pressure and Pulse Do...

Pfizer, Moderna Vaccines Safe & Effective in Children: FDA

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As FDA prepares for a 6/14-15 advisory committee meeting on pediatric Covid-19 vaccines, agency briefing documents find the Pfizer...

Comments Extended on Antimicrobial Drug Use

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Federal Register notice: FDA extends the comment period for a 2/16 notice that requested comments on antimicrobial drug use practi...

FDA OKs Cancer Drugs Faster/Sooner Than EMA: Study

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A new JAMA online study finds that FDA reviews and approves new oncology therapies much faster and sooner than the EMA.

Science Advisory Board Renewal

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Federal Register notice: FDA renews its Science Advisory Board to the National Center for Toxicological Research for an additional...