NIH

COVID-19 Update: HHS Issues Omnibus Advisory Opinion Regarding PREP Immunity

By Yvonne Puig (US), Daphne Calderon (US) & Jeff Wurzburg (US) on April 23, 2020

The HHS Office of the General Counsel has released an important Advisory Opinion that provides insight regarding the interpretation and application of the Secretary’s March 17, 2020 Declaration, which is retroactively effective beginning February 4, 2020. (HL Pulse discussion…

FDA and NIH finalize clinical trial protocol template

Posted on May 18, 2017

On May 2, 2017, the U.S. Food and Drug Administration (“FDA”) and The National Institutes of Health (“NIH”), through the NIH-FDA Joint Leadership Council, released the final version of a clinical trial protocol template in an effort to assist investigators…

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NIH

COVID-19 Update: HHS Issues Omnibus Advisory Opinion Regarding PREP Immunity

FDA and NIH finalize clinical trial protocol template

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