Реальная клиническая практика: данные и доказательства (Aug 2023)

Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making

  • V. G. Borovskaya,
  • A. R. Kasimova

DOI
https://doi.org/10.37489/2782-3784-myrwd-31
Journal volume & issue
Vol. 3, no. 2
pp. 1 – 9

Abstract

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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.

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