Pediatric Drug Research and the FDA (Pharmacology-research, Safety Testing and Regulation) - Softcover
Congress reauthorised 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 reauthorise 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 FDAs review periods and describes challenges identified by stakeholders to conducting studies.
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- PublisherNova Science Pub Inc
- Publication date2013
- ISBN 10 1622577299
- ISBN 13 9781622577293
- BindingPaperback
- Number of pages87
- EditorWashington Kevin L., Bennett Jeff E.
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Book Description Paperback. Condition: new. Paperback. 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. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability. Seller Inventory # 9781622577293
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Pediatric Drug Research and the FDA
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Book Description Condition: New. Editor(s): Washington, Kevin L.; Bennett, Jeff E. Num Pages: 95 pages. BIC Classification: MJW; MMG. Category: (P) Professional & Vocational; (UP) Postgraduate, Research & Scholarly. Dimension: 153 x 229 x 7. Weight in Grams: 156. . 2012. Paperback. . . . . Books ship from the US and Ireland. Seller Inventory # V9781622577293
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Pediatric Drug Research and the FDA
Published by
Nova Science Publishers Inc
(2012)
ISBN 10: 1622577299
ISBN 13: 9781622577293
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Softcover
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Book Description Condition: New. Editor(s): Washington, Kevin L.; Bennett, Jeff E. Num Pages: 95 pages. BIC Classification: MJW; MMG. Category: (P) Professional & Vocational; (UP) Postgraduate, Research & Scholarly. Dimension: 153 x 229 x 7. Weight in Grams: 156. . 2012. Paperback. . . . . Seller Inventory # V9781622577293
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