Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union

Rolling Submissions

Description

In response to a Congressional request, an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the United States and the European Union, including:

Flexibilities, authorities, or mechanisms available to regulators in the United States and the European Union applicable to rare diseases or conditions

Eligible Applicants- Unrestricted

Additional Eligibility Information

No specific eligibility criteria are mentioned, implying broad accessibility for engagement.

Funding TypeotherCategories of Funding Activity- Health and Medicine

Grantor Contact InformationRare Disease Regulatory Policies Study, National Academies of Sciences, Engineering, and MedicineGrantor Emailrarediseaseregpolicystudy@nas.eduOther Grantor InformationThe National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective advice to inform policy with evidence, spark progress and innovation, and confront challenging issues for the benefit of society. They are comprised of three academies: the National Academy of Sciences, the National Academy of Engineering, and the National Academy of Medicine. The organization convenes hundreds of conferences, workshops, and symposia annually, bringing together leading experts from academia, public, and private sectors. Their work focuses on providing high-quality, evidence-based consensus on complex scientific, engineering, and health-related challenges. They produce peer-reviewed reports, publish scientific journals, and serve as a trusted source of expert advice for policymaking. The National Academies mobilize approximately 6,000 top experts each year who volunteer their time and knowledge to conduct policy studies, workshops, and other activities aimed at addressing critical issues facing the nation and world.

Additional InformationThe study aims to address processes for evaluating the safety and efficacy of drugs for rare diseases. It includes evaluating regulatory processes and collaborative efforts between US and EU regulators, considering supplemental data, and providing policy recommendations. Additional URLs:

https://nap.nationalacademies.org/27968

https://www.nationalacademies.org/news/2024/09/to-increase-pace-and-volume-of-drug-approvals-for-rare-diseases-report-recommends-fda-enhance-information-sharing-improve-collaboration

https://nap.nationalacademies.org/resource/27968/One_Pager_Rare_Disease_Drugs.pdf

https://nap.nationalacademies.org/resource/27968/Rare_Disease_Drugs_Recommendations.pdf

https://nap.nationalacademies.org/resource/27968/Highlights_Rare_Disease_Drugs.pdf

Supporting Linkhttps://www.nationalacademies.org/our-work/processes-to-evaluate-the-safety-and-efficacy-of-drugs-for-rare-diseases-or-conditions-in-the-united-states-and-the-european-union

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