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Accutane iPLEDGE Glitches Warrant Start Up Delay, Dermatology Group Urges

Executive Summary

Implementation of the iPLEDGE pregnancy risk management program for Roche's acne therapy Accutane and isotretinoin generics should be postponed until May 1, the American Academy of Dermatology said

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Accutane iPLEDGE Program Glitches Continue Six Months After Launch – AADA

Implementation problems with the iPLEDGE pregnancy risk management program for the acne therapy isotretinoin (Roche's Accutane and generics) may be relieved by eliminating the mandatory one month hiatus between physician office visits, a study by the American Academy of Dermatology Association found

Accutane iPLEDGE Program Glitches Continue Six Months After Launch – AADA

Implementation problems with the iPLEDGE pregnancy risk management program for the acne therapy isotretinoin (Roche's Accutane and generics) may be relieved by eliminating the mandatory one month hiatus between physician office visits, a study by the American Academy of Dermatology Association found

Senators criticize iPLEDGE

A bipartisan group of senators, including Dick Durbin (D-Ill.), Judd Gregg (R-N.H.) and Orrin Hatch (R-Utah), are calling on FDA to fix the iPLEDGE risk management plan covering Roche's Accutane and isotretinoin generics. In a letter to FDA, the senators express concern that the program increases the risks of therapy by unnecessarily causing extended use. The group also complains that iPLEDGE has caused some physicians to stop prescribing the drug. The risk management plan went into effect March 1 (1"The Pink Sheet" Feb. 20, 2006, p. 14)...

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