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Food and
Drug Administration
Dermatologic and Opthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
August 1, 2007
FDA
Disclaimer
The statements contained in this document(s) are those of
the product's sponsor, not FDA, and FDA does not necessarily
agree with the sponsor's statements. FDA has not made a final
determination about the safety or effectiveness of the product
described in this document.
FDA Briefing Material (pdf)
iPLEDGE
sponsor group
Disclaimer
The statements contained in this document(s) are those of
the product's sponsor, not FDA, and FDA does not necessarily agree with the
sponsor's statements. FDA has not made a final determination about the safety
or effectiveness of the product described in this document.
Isotretinoin iPLEDGE program
Briefing Material (pdf)
Isotretinoin iPLEDGE program Addendum:
(added 9/7/07)
Birth Control Workbook (pdf)
Pharmacist Guide to Isotretinoin (pdf)
Prescriber Checklist – FCBP (pdf)
Prescriber Checklist - FnCBP and Male (pdf)
Prescriber Contraception Counseling Guide (pdf)
Flowchart – Patient (pdf)
Flowchart – Pharmacy (pdf)
Flowchart – Prescriber (pdf)
Guide to Best Practices for Isotretinoin (pdf)
Guide to Isotretinoin – FCBP (pdf)
Guide to Isotretinoin - FnCBP and Male (pdf)
Informed Consent - all patients (pdf)
Informed Consent – FCBP (pdf)
Patient Introductory Brochure (pdf)