The Food and Drug Administration Safety and Innovation Act: Provisions and Analyses of User Fees

Perry, James C. (Editor)

ISBN 10: 1629487740 / ISBN 13: 9781629487748

Published by Nova Science Pub Inc, 2013

About this Item

173 pages. 8.75x6.00x0.75 inches. In Stock.

Seller Inventory # zk1629487740

Bibliographic Details

• Title: The Food and Drug Administration Safety and Innovation Act: Provisions and Analyses of User Fees
• Publisher: Nova Science Pub Inc
• Publication Date: 2013
• Language: English
• ISBN 10: 1629487740
• ISBN 13: 9781629487748
• Binding: Hardcover
• Condition: Brand New
• Weight: 0.39 kilograms

About this title

Synopsis

The Food and Drug Administration Safety and Innovation Act (FDASIA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities. Frequently referred to as the user fee reauthorisation act, FDASIA does include four titles relating to user fees. This book focuses on these acts, as well as the prescription drug user fee act, the FDA medical device user fee program and discusses the proposed FDA user fee acts generic drug user fee amendments.