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News & Insights
In the News
May 19, 2023 - Source: RAPS Regulatory Focus
Chris Markus comments on the FDA releasing two draft guidances that aim to help companies comply with PREA study requirements and describes the process for gaining pediatric exclusivity, as well as offer the agency’s current thinking on scientific considerations for drugs meant for children
Featured Lawyers
Christina M. Markus (Chris)
Washington, D.C.