Applying real-world data to support regulatory decision — making in the United States
https://doi.org/10.37489/2588-0519-2021-1-64-69
Abstract
The article describes the legal basis for the application of real-world data to support regulatory decision-making in the United States, as well as the possibility of implementing the relevant approaches in the legislation of the Eurasian Economic Union.
About the Authors
M. A. Borzova
«Trubor» Law Firm
Russian Federation
Russian Federation
Borzova Maria A. - Counsel
Moscow
А. S. Kolbin
First St. Petersburg State Medical University named after I.P. Pavlov
Russian Federation
Russian Federation
Kolbin Alexey S. - Dr. Sci. (Med.), Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine; professor of the Department of Pharmacology, Medical Faculty, St. Petersburg State University
SPIN code: 7966-0845
St. Petersburg
References
1. 21st Century Cures Act of 2016, Public Law 114-255, 130 Stat. 1033 (2016).
2. Federal Food, Drug, and Cosmetic Act of 1938, Public Law 75-71752 Stat. 1040.
3. Framework for FDA’s Real-World Evidence Program. December 2018. Available from: https://www.fda.gov/media/120060/download.
4. Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics. Draft Guidance. May 2019. Available from: https://www.fda.gov/media/124795/download.
5. Christina Purpura. The surge in FDA approvals supported by RWE: A look at three recent FDA decisions. April 2020. Available from: https://aetion.com/evidence-hub/the-surge-in-fda-approvals-supported-by-rwe-a-look-atthree-recent-fda-decisions/.
6. FDA Announces 4 Grant Awards for Projects Exploring the Use of RealWorld Data to Generate Real-World Evidence in Regulatory Decision-Making. November 2020. Available from: https://www.fda.gov/drugs/science-andresearch-drugs/fda-announces-4-grant-awards-projects-exploring-use-realworld-data-generate-real-world-evidence.
7. Решение Совета Евразийской экономической комиссии № 78 «О Правилах регистрации и экспертизы лекарственных средств для медицинского применения» от 03.11.2016 г. [Decision of the Eurasian Economic Commission Council No. 78 «On the Rules of Registration and Expertise of the Medicines for Human Use» dated 03.11.2016 (In Russ).]
8. Решение Совета Евразийской экономической комиссии № 87 «Об утверждении Правил надлежащей практики фармаконадзора Евразийского экономического союза» от 03.11.2016 г. [Decision of the Eurasian Economic Commission Council No. 87 «On Approval of the Rules of Good Practice of Pharmacovigilance of the Eurasian Economic Union» dated 03.11.2016 (In Russ).]
Review
For citations:
Borzova M.A., Kolbin А.S. Applying real-world data to support regulatory decision — making in the United States. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2021;(1):64-69. (In Russ.) https://doi.org/10.37489/2588-0519-2021-1-64-69
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