Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making
https://doi.org/10.37489/2782-3784-myrwd-31
EDN: HOPBUP
Abstract
About 10 years ago, the FDA launched an initiative to expand the role of patients in informing regulators and sponsors about the most serious consequences of the disease and the main treatment goals that can lead to desired medical outcomes. This initiative has grown into four guidance that aim.
About the Authors
V. G. Borovskaya
Federal State Budgetary Educational Institution of Higher Education «First St. Petersburg State Medical University named after Academician I. P. Pavlov» of the Ministry of Health of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Borovskaya Valentina G. — resident of the department of Clinical Pharmacology and Evidence-Based Medicine
RSCI AuthorID: 1106529
St. Petersburg
Competing Interests:
The author declares no conflict of interest.
A. R. Kasimova
Federal State Budgetary Educational Institution of Higher Education «First St. Petersburg State Medical University named after Academician I. P. Pavlov» of the Ministry of Health of the Russian Federation; Federal State Budgetary Institution «National Medical Research Center for Traumatology and Orthopedics named after R. R. Vreden» of the Ministry of Health of the Russian Federation
Russian Federation
Competing Interests:
Russian Federation
Kasimova Alina R. — PhD, associate professor of the department of Clinical Pharmacology and Evidence-Based Medicine Pavlov First Saint Petersburg State Medical University; Clinical pharmacologist of the Department of Clinical Pharmacology Russian Scientific Research Institute of Traumatology and Orthopedics named after R. R. Vreden
RSCI AuthorID: 913606
St. Petersburg
Competing Interests:
The author declares no conflict of interest.
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Review
For citations:
Borovskaya V.G., Kasimova A.R. Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making. Real-World Data & Evidence. 2023;3(2):1-9. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-31. EDN: HOPBUP
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