US FDA Crowdsourcing Pediatric Regulatory Science Research Ideas
With more than 1,600 pediatric and related clinical trials in house, the agency wants ideas for how they can be analyzed to advance pediatric drug development.
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Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement
Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.
Report language includes several mentions of improving trial diversity and recruitment, while bill offers a 5% increase in funding.
Office of Generic Drugs official says the FDA may be able to harmonize its requirements with regulators who do not have a blanket mandate.