Barr Expects Metformin Launch By Early February; Pediatric Bill Signed
Executive Summary
Barr plans to launch its generic version of Bristol-Myers Squibb's Glucophage (metformin) by early February, CEO Bruce Downey said Jan. 10
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FDA hopes that internal process improvements will result in "more clever" requests to companies for pediatric studies under the Best Pharmaceuticals for Children Act
Pediatric Study Requests Would Benefit From Input On Trial Design – Cmte.
FDA hopes that internal process improvements will result in "more clever" requests to companies for pediatric studies under the Best Pharmaceuticals for Children Act
Pediatric Wish List: Longer Exclusivity Reviews, More Public Data
Future legislation should mandate increased public availability of pediatric trial data, Office of Pediatric Therapeutics Director Dianne Murphy said at a June 13 Institute of Medicine drug forum in Washington, D.C