> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Clin-Pharm Considerations for Neonatals
- URL: https://www.fdaweb.com/draft-guide-on-clin-pharm-considerations-for-neonatals/
- Published: 2019-08-02T12:00:00.000Z
- Updated: 2026-09-15T01:41:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144679

*Federal Register* notice: FDA has made available a draft guidance entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” The document was mandated under the FDA Reauthorization Act of 2017 (FDARA). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-08-01/pdf/2019-16375.pdf?ref=fdaweb.com).