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Guide on Circulating Tumor DNA Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Use of Circulating Tumor DNA for Early-Stage Solid Tumor Dr...

More Transparency in Advisory Committee Use Needed: Researchers

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Harvard University researchers who looked at FDAs use of advisory committees for new drugs say reforms in the process would improv...

Paxlovid Widely Available in Pharmacies: Farley

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CDER Office of Infectious Diseases director John Farley answers healthcare provider questions about using Pfizers Paxlovid on auth...

FDA OKs Marketing of New Alzheimers Diagnostic

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FDA permits marketing of a Fujirebio in vitro diagnostic test for Alzheimers disease.

Additional FDA Native Advertising Enforcement Likely: Attorney

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Attorney Dara Levy predicts increased FDA enforcement involving so-called native advertising and other new promotional trends.

ICH Model-Informed Drug Development Roadmap

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The International Council on Harmonization publishes its Model-Informed Drug Development Discussion Group roadmap for future guide...

User Fee Bill Looks to Improve Accelerated Approval, Inspections

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The House Energy and Commerce Committee releases a comprehensive legislative package to reauthorize FDA user fee agreements and en...

Revised Guide on PMA/HDE Supplements During Covid

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FDA posts a revised final guidance entitled Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HD...

3 ICSR Electronic Transmission Guidances

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FDA publishes 3 guidances on implementing an International Council on Harmonization guidance on electronic submission of individua...

Lasik Injury Advocate Urges Action on Misleading Ads

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Vision Advocacy president Paula Cofer writes FDA commissioner Robert Califf urging regulatory action against refractive eye surger...