Isotretinoin manufacturers have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for isotretinoin.
The 19-day lockout, home pregnancy tests, and attestation intervals for counseling people who cannot get pregnant were among the hot topics on the first day of a 2-day meeting.
The FDA announced that two FDA advisory committees will meet in March to discuss proposed changes to the embattled program to minimize burden on patients, pharmacies, and prescribers."
The latest improvement attempt is a tool created by the Isotretinoin Products Manufacturers Group (IPMG), the manufacturers responsible for the FDA-mandated REMS program.