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

James C. Perry (Editor)

Series: Food and Beverage Consumption and Health
BISAC: TEC012000



Volume 10

Issue 1

Volume 2

Volume 3

Special issue: Resilience in breaking the cycle of children’s environmental health disparities
Edited by I Leslie Rubin, Robert J Geller, Abby Mutic, Benjamin A Gitterman, Nathan Mutic, Wayne Garfinkel, Claire D Coles, Kurt Martinuzzi, and Joav Merrick


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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 reauthorization 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. (Imprint: Nova)


The Food and Drug Administration Safety
and Innovation Act (FDASIA, P.L. 112-144)
(Susan Thaul, Erin Bagalman, Amalia K. Corby-Edwards, Judith M. Glassgold, Judith A. Johnson, Sarah A. Lister, Amanda K. Sarata)

Prescription Drug User Fee Act (PDUFA): 2012 Reauthorization as PDUFA V
(Susan Thaul)

The FDA Medical Device User Fee Program
(Judith A. Johnson)

Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA)
(Susan Thaul, Judith A. Johnson)


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