Home > Newsletters > FDAnews Drug Daily Bulletin > Concerns Over ‘FDAAA Effect’ Absent With PDUFA V, FDA Says
FDAnews Drug Daily Bulletin
July 2, 2012 | Vol. 9 No. 129
Concerns Over ‘FDAAA Effect’ Absent With PDUFA V, FDA Says
The FDA should be able to handle the additional requirements of the new iteration of the Prescription Drug User Fee Act (PDUFA V) with little worry of a repeat of the infamously slowed drug reviews from five years ago, agency officials say. The FDA can comfortably handle the requirements of the PDUFA V commitment letter and implement Congress’ demands in the now-finalized legislation, CDER Director Janet Woodcock said Tuesday at the Biotechnology Industry Organization International Convention.
Washington Drug Letter
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.