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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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Sci Transl Med 2020 Jul 29;12(554):eaax2550

Scientific considerations for global drug development.

Wilson JL, Cheung KWK, Lin L, Green EAE, Porrás AI, Zou L, Mukanga D, Akpa PA, Darko DM, Yuan R, Ding S, Johnson WCN, Lee HA, Cooke E, Peck CC, Kern SE, Hartman D, Hayashi Y, Marks PW, Altman RB, Lumpkin MM, Giacomini KM, Blaschke TF


Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

Category: Journal Article, Editorial
PubMed ID: #32727913 DOI: 10.1126/scitranslmed.aax2550
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2020-08-02 Entry Last Modified: 2020-08-09