Food and Drug Administration Amendments Act of 2007 - Best Pharmaceuticals For Children Act (BPCA)

Best Pharmaceuticals For Children Act (BPCA)

  • Encourages more studies in children and promotes the development of treatments for children.
  • Intended to improve FDA and applicant accountability for the agreed-upon pediatric studies.
  • FDAAA broadens the definition of “pediatric studies” to include preclinical studies, and narrows the timeframe for sponsors to qualify for pediatric exclusivity.

Read more about this topic:  Food And Drug Administration Amendments Act Of 2007

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