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Pediatric Drug Research & the FDA
Engelsk Paperback
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Pediatric Drug Research & the FDA
Engelsk Paperback

1.065 kr
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Om denne bog
Congress reauthorized two laws in 2007, the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). PREA requires that sponsors conduct pediatric studies for certain products unless the Department of Health and Human Services'' (HHS) Food and Drug Administration (FDA) grants a waiver or deferral. On June 20th, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs, create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. This book examines how many and what types of products have been studied; describes the number and type of labelling changes and FDA''s review periods and describes challenges identified by stakeholders to conducting studies.
Product detaljer
Sprog:
Engelsk
Sider:
95
ISBN-13:
9781622577293
Indbinding:
Paperback
Udgave:
ISBN-10:
1622577299
Kategori:
Udg. Dato:
4 mar 2013
Længde:
7mm
Bredde:
229mm
Højde:
153mm
Forlag:
Nova Science Publishers Inc
Oplagsdato:
4 mar 2013
Forfatter(e):
Kategori sammenhænge