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 labeling changes and FDA’s review periods and describes challenges identified by stakeholders to conducting studies.
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