Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?

Author:

Ren Zhaoxia,Zajicek Anne

Publisher

Elsevier BV

Subject

Obstetrics and Gynecology,Pediatrics, Perinatology and Child Health

Reference6 articles.

1. Shirkey HC. Conference of Professional and Scientific Societies. 1963;27–28. [Sponsored by Commission on Drug Safety, Chicago, IL.]

2. Thalidomide and congenital abnormalities;McBride;Lancet,1961

3. FDAMA. FDA Modernization Act of 1997: CDER-related documents [online]. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/ Accessed March, 2015.

4. PREA. Pediatric Research Equity Act, Pub. L. No. 108–155, 117 Stat. 1936, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM077853.pdf; 2003 Accessed March, 2015.

5. Federal Register Notices. List of drugs for which pediatric studies are needed. http://bpca.nichd.nih.gov/prioritization/status/Documents/Federal_Register_01-21-2003.pdf; 2003:68, No. 13.

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