Better Pharmaceuticals for Children: Assessment & Opportunities: Hearing Before the Committee on Health, Education, Labor, & Pensions, U.S. Senate

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Our Price: $25.00

Year: 2001
Pages: 88
Binding Paperback

Product Code: 0756727537

Description

James M. Jeffords. 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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