Join our mailing list!
(Your shopping cart is empty)
Diane Publishing Books
New Drug Approval: FDA Needs to Enhance its Oversight of Drugs Approved on the Basis of Surrogate Endpoints
Marcia Crosse (au)
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.
Southern World: Trade & Travel Routes
Between Friends: Writing Women Celebrate Friendship
Gates of the Alamo
For Your Own Good: The Roots of Violence in Child-Rearing
How to Spec Type
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
Become an Affiliate
Send Us Feedback
Copyright ï¿½ 2004 Diane Publishing Company. All Rights Reserved.