Evaluation of Sex Differences in Clinical Investigations: Guidance for Industry
describes the FDA guideline of 22 July 1993 as lifting a restriction on most women with childbearing potential entering Phase 1 and early Phase 2 trials and as now encouraging their participation.
describes the FDA guideline of 22 July 1993 as lifting a restriction on most women with childbearing potential entering Phase 1 and early Phase 2 trials and as now encouraging their participation.
Written from the full text read 2026-10-15.
What our sources record
Reproduced as it was written when this source was checked, figures and all.
January 2025, Docket No. FDA-2013-S-0610. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-sex-differences-clinical-investigations. Full text read: describes the FDA guideline of 22 July 1993 as lifting a restriction on most women with childbearing potential entering Phase 1 and early Phase 2 trials and as now encouraging their participation.