Tag archives: NIH

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

Photo of Yvonne Puig (US)Photo of Daphne Andritsos Calderon (US)Photo of Jeff Wurzburg (US)By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on Posted in Coronavirus, General, News from DC, Regulatory
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 here).  The Declaration provides immunity to certain individuals and entities for liability against “all claims for … Continue reading

FDA and NIH finalize clinical trial protocol template

Health Law PulseBy on Posted in Regulatory
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 conducting clinical trials and to create cost and time efficiencies in the medical product development … Continue reading
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