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FDA Plans Public Meeting On Pediatric Drug Research, Labeling Issues

By Donna Haseley
October 24, 2019 at 4:08 PM
FDA will gather advice from stakeholders on whether pediatric research and labeling policies need to be revamped at a public meeting Nov. 21. The agency will use the input to draft a report updating Congress on its implementation of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), FDA explained in a Federal Register notice Thursday (Oct. 24). FDA hopes to learn how the two pediatric laws have affected patients, industry, academia and other stakeholders...


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