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A01=Joav Merrick
A01=Søren Ventegodt
Age Group_Uncategorized
Age Group_Uncategorized
Author_Joav Merrick
Author_Søren Ventegodt
automatic-update
B01=Jeff E. Bennett
B01=Kevin L. Washington
Category1=Non-Fiction
Category=MJW
Category=MMG
COP=United States
Delivery_Delivery within 10-20 working days
Language_English
PA=In stock
Price_€50 to €100
PS=Active
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Pediatric Drug Research & the FDA

English

By (author): Joav Merrick Søren Ventegodt

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. See more
Current price €93.09
Original price €97.99
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A01=Joav MerrickA01=Søren VentegodtAge Group_UncategorizedAuthor_Joav MerrickAuthor_Søren Ventegodtautomatic-updateB01=Jeff E. BennettB01=Kevin L. WashingtonCategory1=Non-FictionCategory=MJWCategory=MMGCOP=United StatesDelivery_Delivery within 10-20 working daysLanguage_EnglishPA=In stockPrice_€50 to €100PS=Activesoftlaunch
Delivery/Collection within 10-20 working days
Product Details
  • Weight: 156g
  • Dimensions: 155 x 230mm
  • Publication Date: 04 Mar 2013
  • Publisher: Nova Science Publishers Inc
  • Publication City/Country: United States
  • Language: English
  • ISBN13: 9781622577293
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