Join our mailing list!
(Your shopping cart is empty)
Diane Publishing Books
Food & Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, & Other Agency Activities
Janet Heinrich (au). In 1992, the Prescription Drug User Fee Act (PDUFA) was enacted to provide additional resources for the FDA to speed up the process of reviewing applications for new drugs & biological products. This report examines: (1) how PDUFA has affected the funding & approval times for FDA’s review of new drug & biologic applications, (2) whether PDUFA has had an effect on the funding & oper. of FDA’s non-PDUFA activities, (3) whether the workload, attrition, & non-professional development of FDA reviewers have changed since the user fee program was reauthorized in 1997, & (4) how the rate of drug withdrawals from the market has changed since PDUFA was enacted in 1992 & what actions are being taken by FDA to monitor adverse drug effects. Charts & tables.
Anti-Depressant Survival Program: How to Beat the Side Effects & Enhance the Benefits of Your Medication
Lamborghini: Supercar Supreme
Asia Rising: Why America Will Prosper as Asia’s Economies Boom
History of the New York Central System
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.