FDA Implements AADA's iPLEDGE Recommendations
WASHINGTON, Dec. 5, 2023 /PRNewswire/ -- The FDA agreed to require important American Academy of Dermatology's (AAD) recommended changes to the iPLEDGE program that will alleviate administrative burdens for dermatologists.
- "The FDA supported the AADA's critical recommendations that include allowing for continued use of at home and non-CLIA pregnancy tests."
- In 2023, 300 AAD members sent about 600 messages to the FDA urging changes to iPLEDGE REMS Program.
- These grassroots efforts, combined with AAD's strong advocacy led by its iPLEDGE Workgroup, including testifying during an FDA hearing in March, convinced the FDA to require modifications to the iPLEDGE REMS to minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin.
- The AAD has been fighting for these changes since 2021, when the FDA transitioned to a new iPLEDGE platform that malfunctioned and disrupted treatment for many patients.