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iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data

Executive Summary

Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.

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