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BIO responded to the GAO request for feedback regarding the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The comments recognize that these dual statutes governing pediatric research have been remarkably successful in ensuri

BIO is concerned about CMS’ decision to open an NCA on a recently-approved therapy because it could establish a precedent that affects Medicare patient access to a wide range of innovative drug and biological therapies on a national basis.