The Pediatric Research Equity Act aims to close the gap in pediatric drug testing but faces significant delays in study completion. Rare disease designations exempt nearly half of new drugs from ...
Please provide your email address to receive an email when new articles are posted on . No drugs approved between 2017 and 2020 were subjected to post-approval pediatric testing requirements. After ...
Please provide your email address to receive an email when new articles are posted on . Out of 323 drugs, only 10% completed testing in children before receiving FDA approval. Rare disease ...
On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug ...
On February 3, 2026, the President signed the Consolidated Appropriations Act of 2026 (the CAA) into law and ended a partial government shutdown. 1 The Act included two changes that directly affect ...
Mary Carmack is a researcher in the Pediatric Therapeutics and Regulatory Science Initiative in the Computational Health Informatics Program at Boston Children’s Hospital, in Boston, Massachusetts.
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