Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making
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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| Main Authors: | , |
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| Format: | Article |
| Language: | Russian |
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Publishing House OKI
2023-08-01
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| Series: | Реальная клиническая практика: данные и доказательства |
| Subjects: | |
| Online Access: | https://www.myrwd.ru/jour/article/view/36 |
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| _version_ | 1849697467294023680 |
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| author | V. G. Borovskaya A. R. Kasimova |
| author_facet | V. G. Borovskaya A. R. Kasimova |
| author_sort | V. G. Borovskaya |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9c1cbe9198bb4e9babeef27b281eeafc |
| institution | DOAJ |
| issn | 2782-3784 |
| language | Russian |
| publishDate | 2023-08-01 |
| publisher | Publishing House OKI |
| record_format | Article |
| series | Реальная клиническая практика: данные и доказательства |
| spelling | doaj-art-9c1cbe9198bb4e9babeef27b281eeafc2025-08-20T03:19:12ZrusPublishing House OKIРеальная клиническая практика: данные и доказательства2782-37842023-08-01321910.37489/2782-3784-myrwd-3134Overview of FDA guidelines for patient engagement in medical product development and regulatory decision makingV. G. Borovskaya0A. R. Kasimova1Federal 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 FederationFederal 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 FederationAbout 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.https://www.myrwd.ru/jour/article/view/36guidancepfddpatient-focused drug development |
| spellingShingle | V. G. Borovskaya A. R. Kasimova Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making Реальная клиническая практика: данные и доказательства guidance pfdd patient-focused drug development |
| title | Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making |
| title_full | Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making |
| title_fullStr | Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making |
| title_full_unstemmed | Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making |
| title_short | Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making |
| title_sort | overview of fda guidelines for patient engagement in medical product development and regulatory decision making |
| topic | guidance pfdd patient-focused drug development |
| url | https://www.myrwd.ru/jour/article/view/36 |
| work_keys_str_mv | AT vgborovskaya overviewoffdaguidelinesforpatientengagementinmedicalproductdevelopmentandregulatorydecisionmaking AT arkasimova overviewoffdaguidelinesforpatientengagementinmedicalproductdevelopmentandregulatorydecisionmaking |