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pro vyhledávání: '"Ginny Beakes-Read"'
Autor:
Ramy Khalil, Judith C. Macdonald, Andrew Gustafson, Lina Aljuburi, Fabio Bisordi, Ginny Beakes-Read
Publikováno v:
Frontiers in Medicine, Vol 10 (2023)
Cloud-based regulatory platforms have the potential to substantially transform how regulatory submissions are developed, transmitted, and reviewed across the full life cycle of drug development. The benefits of cloud-based submission and review inclu
Externí odkaz:
https://doaj.org/article/3aecfc41a1db4ca7b937cece60c41463
Publikováno v:
Therapeutic innovationregulatory science. 56(5)
The accelerated approval pathway has been criticized recently for employing lower regulatory standards than traditional drug approval, undue delays in withdrawing approvals of drugs for which studies have not confirmed clinical benefit, and confirmat