October 27, 2020: MDUFA performance goals need to be more patient-centered by including specific metrics pertaining to safety and effectiveness, both pre-market and post-market, and improving patients and consumer advocates’ access to meet with FDA decision-making officials. That will help provide the safeguards that patients and consumers deserve.
Read More »On Health Policy
Open Letter to Stephen M. Hahn, M.D., Commissioner of the Food and Drug Administration: #ProtectTheFDA
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 […]
Read More »NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population
August 31, 2020: We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.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
August 13, 2020: 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.
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