BioCentury on BioBusiness,
Table: PDUFA V Commitments
Back to the parent article
Monday, July 2, 2012
In addition to reauthorizing the Prescription Drug
User Fee Act, which will generate more than $4 billion in user fees for
FY13-FY17, the Food and Drug Administration Safety and Innovation Act (S.3187)
contains several measures intended to reform FDA. Source: S.3187; FDA
performance goals and procedures
FDA to use Fast Track designation and accelerated approval for "a broad
range of serious or life threatening diseases or conditions"
caps on conflict-of-interest waivers for advisory committee members
anti-infective drugs against pathogens with "potential to pose a serious
threat to public health" receive Priority Review and five years
of exclusivity in addition to any Orphan, NCE or pediatric exclusivity
words displayed of
To read this article, you must be an Archives subscriber. Please choose one of the options below.
All contents Copyright © 1993-2015 BioCentury Publications, Inc. ALL RIGHTS RESERVED. All use of this Web Site and its contents is governed by the BioCentury User Agreement
. The contents of this Web Site are protected under U.S. and foreign copyright and intellectual property laws, and no part of this Web Site or its contents may be photocopied, reproduced or retransmitted in any form without the written consent of BioCentury, which may be requested from Reprints/Permissions
. BioCentury®; The Bernstein Report on BioBusiness™; The BioCentury 100™; The Clear Route to ROI™; Because Real Intelligence is Hard to Find™; BCIQ™; and BioPharma's Knowledge Center™; are trademarks of BioCentury Publications, Inc., P.O. Box 1246, San Carlos, CA 94070. SciBX® and SciBX: Science-Business eXchange® are trademarks of Nature America, Inc. that are jointly used by BioCentury Publications, Inc. and Nature America, Inc.
Whether you want an individual subscription or need a global group license, we have the products,
the experience and the customer support that biopharma executives, researchers, investors, service providers,
and industry stakeholders have trusted for nearly two decades.
Let our Subscriber Services team customize the best intelligence package available in the industry to meet your needs.
Free Trial 4 Weeks of Access
Get a 4-week free trial subscription to see the important articles you are missing.
Get 4 Weeks Free
Thanks for purchasing this article.
Please bookmark this url for future reference.
We have also sent you a confirming e-mail with a receipt and this same url for your
close [ X ]