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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Bibliographic Details
Main Authors: D. V. Goryachev, N. E. Uvarova, G. V. Shukshina
Format: Article
Language:Russian
Published: OOO “Vashe Tsifrovoe Izdatelstvo” 2020-09-01
Series:Ведомости Научного центра экспертизы средств медицинского применения
Subjects:
Online Access:https://www.vedomostincesmp.ru/jour/article/view/306