Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail
-

PDUFA FY 2000 Shift in Worldwide NME Introductions

Only 43 percent of the NMEs approved in the U. S. in 1991-1995, primarily pre-PDUFA submissions, received that approval within a year of first introduction on the world market. That percentage almost doubled to 80 percent for the NMEs approved in the U.S. from 1996-1998, primarily post-PDUFA submissions.

 

Back to Report

-
-