Open AccessRegulatory Affairs 101: Introduction to Expedited Regulatory Pathways
Author(s) -
Cox Erica M.,
Edmund Anita V.,
Kratz Erica,
Lockwood Sarah H.,
Shankar Aishwarya
Publication year - 2020
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12745
Subject(s) - regulatory affairs , regulatory science , marketing authorization , authorization , regulatory agency , food and drug administration , drug approval , timeline , regulatory authority , medicine , agency (philosophy) , drug development , clinical trial , medline , prior authorization , business , drug , pharmacology , political science , bioinformatics , public administration , computer security , pathology , history , philosophy , archaeology , epistemology , computer science , law , biology
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.