> ## 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 Hormonal Drug Product Development
- URL: https://www.fdaweb.com/draft-guide-on-hormonal-drug-product-development/
- Published: 2019-07-12T12:00:00.000Z
- Updated: 2026-09-15T01:37:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144519

*Federal Register* notice: FDA has made available a draft guidance entitled “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.” The document describes FDA’s current thinking on key design considerations for these trials to help with development of such products for contraception. However, it does not address developing contraceptive devices. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-07-12/pdf/2019-14855.pdf?ref=fdaweb.com).