Best Pharmaceuticals for Children Act: report together with dissenting views (to accompany H.R. 2887) (including cost estimate of the Congressional Budget Office).
U.S. G.P.O., 2001 - Medical - 58 pages
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$1 million 107TH CONGRESS 180-day generic exclusivity 180-day period amended approved application approved drugs atric Best Pharmaceuticals bill Board bylaws CBO assumes CBO estimates Children Act clause clinical Commissioner of Food conduct contract contract research organizations Cosmetic Act Cosmetic Act 21 costs days after receiving deﬁned direct spending Director of NIH Drug Administration drug application drug under section DRUGS LACKING EXCLUSIVITY effective employees enactment Estimated Authorization Level Estimated Outlays FDA’s Federal Food ﬁrst ﬁscal year 2002 ﬁve Food and Drugs Foundation for Pediatric grants holders of approved identiﬁed Institutes of Health labeling changes list of drugs manufacturer Medicaid million in 2002 National Institutes ofﬁcers paragraph pedi Pediatric Advisory Subcommittee PEDIATRIC INFORMATION pediatric labeling pediatric population Pediatric Research pediatric studies pediatric supplements Pediatric Therapeutics Pharmaceuticals for Children reauthorized require revenues ROLL CALL VOTE Secretary section 505A sivity six months speciﬁc sponsor Study of Drugs subparagraph subsection tion written request