Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways.

Autor: Cox EM; Denali Therapeutics Inc., South San Francisco, California, USA., Edmund AV; Impact Clinical, LLC, Escondido, California, USA., Kratz E; Denali Therapeutics Inc., South San Francisco, California, USA., Lockwood SH; Denali Therapeutics Inc., South San Francisco, California, USA., Shankar A; Denali Therapeutics Inc., South San Francisco, California, USA.
Jazyk: angličtina
Zdroj: Clinical and translational science [Clin Transl Sci] 2020 May; Vol. 13 (3), pp. 451-461. Date of Electronic Publication: 2020 Feb 06.
DOI: 10.1111/cts.12745
Abstrakt: Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the marketing authorization application. Review by regulatory authorities to evaluate whether the data support a positive benefit/risk profile takes many months, adding additional time before patients may access therapy. In this paper, we discuss the various opportunities the US Food and Drug Administration and the European Medicines Agency offer to expedite the drug development and regulatory approval timelines for drugs intended to treat serious diseases and unmet medical needs.
(© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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