Pediatric Sedatives and the Food and Drug Administration (FDA): Challenges, Limitations, and Drugs in Development

Author:

Bollinger Lisa L.,Yao Lynne P.

Publisher

Springer International Publishing

Reference24 articles.

1. US Food and Drug Administration. Code of federal regulations title 21 subpart D: drugs for human use, part 314.126. Washington, DC: US Government Printing Office; 2012.

2. US FDA. Draft guidance for industry. Demonstrating substantial evidence of effectiveness for human drug and biological products. 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products. Accessed 16 Jan 2020.

3. Wilson JT. An update on the therapeutic orphan. Pediatrics. 1999;104(3):585–90.

4. Roberts R, Rodriguez W, Murphy D, et al. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA. 2003;290:905–11.

5. U.S. Census Bureau. Current population reports. http://www.childstats.gov/americaschildren. Accessed 2 Nov 2010.

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