Food & Drug Administration Safety & Innovation Act

Provisions & Analyses of User Fees

Buch | Hardcover

157 Seiten

2014
Nova Science Publishers Inc (Verlag)
978-1-62948-774-8 (ISBN)

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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.

Preface; The Food & Drug Administration Safety & Innovation Act (FDASIA, P.L. 112-144); Prescription Drug User Fee Act (PDUFA): 2012 Reauthorization as PDUFA V; The FDA Medical Device User Fee Program; Proposed FDA User Fee Acts: Generic Drug User Fee Amendments of 2012 (GDUFA) & Biosimilar User Fee Act of 2012 (BSUFA); Index.

Erscheint lt. Verlag	1.3.2014
Verlagsort	New York
Sprache	englisch
Maße	155 x 230 mm
Gewicht	392 g
Themenwelt	Technik ► Lebensmitteltechnologie
ISBN-10	1-62948-774-0 / 1629487740
ISBN-13	978-1-62948-774-8 / 9781629487748
Zustand	Neuware