The iPLEDGE program is a risk evaluation and mitigation strategy (REMS). The Food and Drug Administration (FDA) may require a REMS to help ensure that a medication’s benefits outweigh its risks. A ...

In December 2021, major changes took effect in the iPLEDGE program, the US Food and Drug Administration (FDA)–required safety program for managing the risks of isotretinoin's teratogenicity and ...

March 9, 2006 (San Francisco) — The largest and arguably most complex risk-management program ever undertaken by the US Food and Drug Administration is sparking a commensurate measure of controversy — ...

Please provide your email address to receive an email when new articles are posted on . The AAD and the FDA recommended changes to the iPledge system, but none have yet taken place. The AAD’s iPledge ...

It has been 13 years since the U.S. Food and Drug Administration took a bold step to prevent birth defects caused by the only drug that can cure severe acne. Women were still getting pregnant while ...

WASHINGTON The Food and Drug Administration announced that Covance, the developer of the iPLEDGE risk management program has fully implemented the program revisions approved by the FDA on Oct. 3. The ...

Pre-iPledge, there was the Accutane Pregnancy Prevention Program, which was developed in the late 1980s. It asked much of the same things iPledge does: monthly pregnancy tests, use of contraception, ...

Please provide your email address to receive an email when new articles are posted on . iPLEDGE requires participating pharmacies to have an identifying number, which jails and prisons do not have.

Dermatologists have complained that the U.S. Food and Drug Administration's iPledge program is delaying treatment for patients who require the drug Accutane. The program, which was adapted six months ...