5466940-POS-735348-04b.indd

ACCP 2015 - For multiple decades, there was a presumption that women of child-bearing age should automatically be excluded from any clinical study. The 1977 FDA guideline, "General Consideration for the Clinical Evaluation of "Drugs," recommended excluding women of child-bearing potential from Phase I and Phase II clinical study participation until reproductive toxicity studies and evidence of efficacy was available.