H.R.2589 - Federal Government - To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.
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Please upgrade your Flash Player Latest Update: Wednesday, July, 09th 2008 To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. 6/6/2007--Introduced. Improving Pharmaceuticals for Children Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions relating to market exclusivity for pediatric drug studies on new or already approved drugs to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than one year prior to the expiration of such period. Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if such formulation is not introduced onto the market within one year; and (2) order the labeling of a drug to include information [...]
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