Better Pharmaceuticals for Children Assessment and Opportunities Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate One Hundred Seventh Congress,
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9780756727536
ISBN:0756727537
Publisher: DIANE Publishing Company Summary: Assesses the impact of the pediatric exclusivity provision granting a pharmaceutical co. an additional 6 months of market exclusivity for new or marketed drugs in exchange for conducting pediatric studies requested by the FDA. The hearing was held before the provision was set to expire on Jan. 1, 2002. Witnesses: Janet Woodcock, Center for Drug Eval. & Res., FDA; Janet Heinrich, Public Health Issues, GAO; Robert Ward [read more]- 30-Day No-Hassle Returns
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9780756727536
ISBN:
0756727537
Publisher: DIANE Publishing Company
Assesses the impact of the pediatric exclusivity provision granting a pharmaceutical co. an additional 6 months of market exclusivity for new or marketed drugs in exchange for conducting pediatric studies requested by the FDA. The hearing was held before the provision was set to expire on Jan. 1, 2002. Witnesses: Janet Woodcock, Center for Drug Eval. & Res., FDA; Janet Heinrich, Public Health Issues, GAO; Robert Ward, Comm. on Drugs, Amer. Acad. of Pediatrics; Stephen Spielberg, Pediatric Drug Dev't., Janssen Pharmaceut.; John Golenski, RX Health Value; Larry McAndrews, Nat. Assoc. of Children's Hosp.; John Mahan, Children's Hosp., Columbus, OH. Prepared state.: Amer. Acad. of Child & Adol. Psych., & Generic Pharm. Assoc.
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