On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug ...
There has been recent progress on the development of pediatric drug formulations, but further development of better medicines for children should focus on a certain set of priorities, according to a ...
Changes in the regulatory environment in the United States and European Union have the potential to advance the concept of precision medicine to children with cancer. Preclinical testing of targeted ...
Introduction Pediatric Pharmacology Disasters Testing Drugs in Children Legal and Regulatory Developments: Pediatric Pharmacology in the United States References Legal and Regulatory Developments: ...
Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals for Children Act (BPCA) was enacted in 2002 to improve this ...
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