Accutane iPLEDGE plan under fire by doctors ...
The iPLEDGE program, a risk management plan to prevent pregnancy during isotretinoin therapy, is being called too cumbersome and difficult to manage by dermatologists. The program's start date is set for March 1.
Accutane iPLEDGE plan under fire by doctors ...
The iPLEDGE program, a risk management plan to prevent pregnancy during isotretinoin therapy, is being called too cumbersome and difficult to manage by dermatologists. The program's start date is set for March 1. However, prescribers and pharmacies have raised concerns with the new program, calling it too difficult to implement. The American Academy of Dermatologists (AAD) said it has received hundreds of complaints from physicians who've had trouble enrolling patients and have experienced long wait times on the phone when they called for help. AAD said it is dismayed that the FDA is going ahead with its March 1 start date. The FDA said it has received questions about physician prescribing, patient access, and pharmacy dispensing, but it is working with the sponsors of approved isotretinoin applications to find solutions prior to the March 1 start date. Pharmacists can access the iPLEDGE call center at 1-(866) 495-0654 or visit http://www.ipledgeprogram.com/
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
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