Marketing Authorisation Based on Incomplete Clinical Data: International Experience and Prospects
No new drug can be used in clinical practice without marketing authorisation. Acquisition of the necessary amount of clinical data may take several years, which is especially critical for pernicious diseases for which no alternative therapy is available. Lack of treatment options creates conditions...
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| Main Authors: | D. V. Goryachev, N. E. Uvarova, G. V. Shukshina |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2020-09-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/306 |
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