Join our mailing list!

Official PayPal Seal

(Your shopping cart is empty)

  Home > Diane Publishing Books >

New Drug Approval: FDA Needs to Enhance its Oversight of Drugs Approved on the Basis of Surrogate Endpoints
New Drug Approval: FDA Needs to Enhance its Oversi

Our Price: $25.00
By Marcia Crosse (au)
Year: 2009
Pages: 71
Binding Paperback

Product Code: 1437924603

Before approving a drug, the FDA assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint (SE) -- a laboratory measure, such as blood pressure -- instead of more direct clinical evidence, like preventing strokes. After approval, FDA requires a drug sponsor to further study the drug. There have been concerns about FDA's reliance on SE and its oversight of post-marketing studies (PS). This report provides info. on: (1) all drug applications approved based on SE in FDA's accelerated approval process; (2) a subset of applications for potentially innovative drugs approved based on SE under FDA's traditional process; and (3) FDA's oversight of PS. Illustrations.

Share your knowledge of this product with other customers... Be the first to write a review
Diane Publishing Co
PO Box 617
Darby, PA 19023-0617
 About Us
 Become an Affiliate
 Privacy Policy
 Send Us Feedback
Company Info | Advertising | Product Index | Category Index | Help | Terms of Use
Copyright � 2004 Diane Publishing Company. All Rights Reserved.
Built with Volusion