Scientific Publications by FDA Staff

Clin Pharmacol Ther 2013 Aug;94(2):230-42

Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.

Khin NA, Yang P, James Hung HM, Maung-U K, Chen YF, Meeker-O'Connell A, Okwesili P, Yasuda SU, Ball LK, Huang SM, O'Neill RT, Temple R

Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to FDA in new drug applications. This paper will discuss the FDA experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between studies in the U.S. and outside the U.S. in effectiveness and safety outcomes, and the FDA approach to acceptance of these trials.