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
In September 2020, medical and public health experts wrote to the FDA
Commissioner to express concern about political influence on FDA’s COVID-19 vaccine
decision-making, saying it could potentially compromise scientific integrity and public trust. The
open letter called on Commissioner Hahn to ensure vaccine approvals remain independent,
transparent, data-driven, and free from partisan pressure, urging actions like consulting with
other scientific bodies before issuing emergency authorizations.
NCHR’s Public Comments on the FDA’s Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population
August 31, 2020: We have several recommendations regarding the FDA’s draft guidance regarding the development of anti-infective drugs for the pediatric population.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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