The FDA and the new biology.
The translation of basic science discoveries to clinical application is dependent on the demonstrated efficacy in humans of the technology but even as importantly on the therapeutic agent or device conforming to the standards of the US Food and Drug Administration (FDA) leading to approval. In this editorial, we propose that the FDA consider a modified process to support the more rapid development of novel agents while furthering the understanding of the risk and benefits of new therapeutics as they are utilized following approval.
Simari
Robert D
RD
Division of Cardiovascular Diseases, Heart and Lung Research Center, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. simari.robert@mayo.edu
Chen
Horng
H
Burnett
John C
JC
D001695:Biology / Q000639:trends*; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000503:physiopathology; D002637:Chest Pain / Q000175:diagnosis / Q000503:physiopathology; D002908:Chronic Disease; D017277:Drug Approval; D004730:Endothelium, Vascular / Q000503:physiopathology; D023281:Genomics; D006801:Humans; D008833:Microcirculation; D040901:Proteomics; D057170:Translational Research, Biomedical; D014481:United States; D014486:United States Food and Drug Administration; D020257:Ventricular Remodeling