Food & Drug Administration Safety & Innovation Act : Provisions & Analyses of User Fees
Book Details
Format
Hardback or Cased Book
ISBN-10
1629487740
ISBN-13
9781629487748
Publisher
Nova Science Publishers Inc
Imprint
Nova Science Publishers Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Feb 1st, 2014
Print length
157 Pages
Weight
388 grams
Dimensions
22.70 x 15.60 x 1.80 cms
Ksh 28,800.00
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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.
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