September 25, 2020 We, the undersigned experts in regulatory science and medicine, are concerned about decisionmaking at the FDA related to the COVID-19 crisis. We are writing because there have been a number of headlines recently about the adequacy of the FDA’s evidentiary standards related to COVID-19 vaccines and its authority to make science-driven assessments […]
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NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population
We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.
Read More »NCHR’s Public Comments on the Scientific Report of the 2020 Dietary Guidelines Advisory Committee
We support many of the recommendations of the Dietary Guidelines Advisory Committee. However, we also have some concerns.
Read More »NCHR joins Nonprofits in asking FDA to only allow Covid vaccine distribution after phase 3 trials completed
August 10, 2020. Experts urge that COVID-19 vaccines are made widely available only after the Food and Drug Administration (FDA) has been able to evaluate safety and efficacy data from completed Phase 3 clinical trials.
Read More »NCHR joins Nonprofits in criticizing White House blocking CDC from sharing Covid-19 data
July 23, 2020. Nonprofit coalition asks Sec. Azar to rescind guidance to stop reporting coronavirus data to CDC and send it only to HHS.
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