Susan Thaul, Coordinator
Specialist in Drug Safety and Effectiveness
Erin Bagalman
Analyst in Health Policy
Amalia K. Corby-Edwards
Analyst in Public Health and Epidemiology
Judith M. Glassgold
Specialist in Health Policy
Judith A. Johnson
Specialist in Biomedical Policy
Sarah A. Lister
Specialist in Public Health and Epidemiology
Amanda K. Sarata
Specialist in Health Policy/Acting Section Research Manager
TheFood and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144,amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand theauthority of the Food and Drug Administration (FDA) in performing itshuman drug, biological product, and medical device responsibilities.Frequently referred to as the user fee reauthorization act, FDASIA does include fourtitles relating to user fees. Titles I and II reauthorize the prescription drugand medical device user fee programs (PDUFA and MDUFA). Titles III and IVauthorize new user fee programs for generic drugs (GDUFA) and biosimilarbiological products (BSUFA).
Title V of FDASIA reauthorizes and amends provisions of the BestPharmaceuticals for Children Act (BPCA) and the Pediatric Research EquityAct (PREA); it also includes other pediatric research sections. Title VIaddresses the regulation of medical devices across such diverse topics asclarifying the definition of a custom device; extending for another five yearsthe ability of the manufacturer of a humanitarian use device (one with alimited number of potential users) to make a profit on sales for pediatricuse and the expansion of that ability to sales for nonpediatric use; andauthorizing the Secretary of Health and Human Services to enter intoarrangements with nations regarding harmonization of device regulation.
Titles VII through X address the regulation of human drugs, highlighting theareas of supply chain security, anti-infective product developmentincentives, expedited development and review of drugs, and drug shortages.Title XI contains a miscellany of provisions including, for example, medicalgas product regulation, advisory committee conflicts of interest, and requiredreports and guidance from the Secretary.
For each title of FDASIA, this report provides a brief policy backgroundnarrative and an overview of provisions in P.L. 112-144. An appendix liststhe time-specific requirements of federal entities in FDASIA.
Date of Report: February 4, 2013
Number of Pages: 49
Order Number: R42680
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