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

 
• By Brenda Sandburg

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.

Isotretinoin foil package
US FDA advisory committee recommends changes to iPLEDGE isotretinoin REMS program • Source: Shutterstock

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