Stakeholders responding to two draft guidances released by the US Food and Drug Administration’s (FDA) concerning exclusivity extensions for written request (WR) studies under the Pediatric Research ...
In a move that could ruffle the feathers of pharmaceutical companies, the US Food and Drug Administration (FDA) says it aims to be more selective when awarding six-month exclusivity extensions for the ...
On February 3, 2026, President Trump signed into law the Mikaela Naylon Give Kids A Chance Act as part of the Consolidated Appropriations Act (CAA) of 2026. The CAA codifies FDA's interpretation of ...
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