The Pediatric Studies Initiative: After 15 Years Have We Reached the Limits of the Law?

Author:

Milne Christopher-Paul,Davis Jonathan

Publisher

Elsevier BV

Subject

Pharmacology (medical),Pharmacology

Reference14 articles.

1. Pediatric Drug Development: Concepts and Applications,2013

2. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications;DiMasi;Clin Ther,2013

3. Pediatric information in drug product labeling;Sachs;JAMA,2012

4. Yao L. FDA takes steps to encourage pediatric drug studies. FDA Voice. August 26, 2013. http://blogs.fda.gov/fdavoice/index.php/tag/food-and-drug-administration-safety-and-innovation-act-fdasia/. Accessed October 25, 2013.

5. IOM review of FDA-approved biologics labeled or studied for pediatric use;Field;Pediatrics,2013

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