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Harmonizing the Common Rule and U.S. Food and Drug Administration Human Subjects Research Regulations

On September 28, 2022, the U.S. Food and Drug Administration issued two Notices of Proposed Rule Making to harmonize FDA’s regulations pertaining to human subjects research and the review of cooperative research by a single institutional review board with those of the Federal Policy for the Protection of Human Subjects. Earlier in September, FDA also issued a draft guidance entitled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

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COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by FDA, EMA, MHRA and PMDA

Practices: Health Care

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The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, national authorities have issued guidance for sponsors, investigators and institutional review boards (IRBs)/research ethics committees (RECs) regarding the conduct of clinical trials. The chart below summarizes guidance from the U.S. Food and Drug Administration (“FDA”) (updated March 27, 2020), the European Medicines Agency (“EMA”) (dated March 27, 2020), the United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”) (updated March 24, 2020), and Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) (dated March 27, 2020).

View the PDF to read the guidance.

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