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Proposed Rule Seeks to Promote Adoption of Value-Based Purchasing Arrangements

On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, if finalized, would modify significantly the current Medicaid Drug Rebate Program (MDRP) regulations, generally (but not entirely) directions long-favored by drug makers.

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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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