Up | AC Home Page

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)

---