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# UCB on Pregnancy Safety Studies
- URL: https://www.fdaweb.com/ucb-on-pregnancy-safety-studies/
- Published: 2023-11-30T12:00:00.000Z
- Updated: 2026-09-14T14:17:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155895

Global biopharm UCB associates itself with comments submitted by Pharmaceutical Research and Manufacturers of America on an FDA workshop on optimizing the use of post-approval pregnancy studies and the development of a framework. It [asks](https://downloads.regulations.gov/FDA-2023-N-3104-0005/attachment%5F1.docx?ref=fdaweb.com) the agency to further consider these points:

- routine pharmacovigilance is currently considered out of the scope of the framework but is mentioned as a source of data for descriptive studies; and
- additional agency discussion is needed on the specifics of various study design options.

UCB also asks FDA to consider adding a definition of risk to the framework development and consider integrating in the framework the uncontrolled disease activity risk for the unborn child and the mother during pregnancy.