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 ...

Please provide your email address to receive an email when new articles are posted on . The FDA has issued a notification to isotretinoin manufacturers to modify the iPledge Risk Evaluation 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 — ...

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 ...

WHITE PLAINS, N.Y., July 31, 2007 – Despite a mandatory program designed to prevent pregnant women from being exposed to the anti-acne medication Accutane and similar medications containing ...

More than 120 pregnancies were exposed to a birth defect-causing agent during the first year of iPledge, a mandatory program designed to prevent pregnant women from being exposed to the anti-acne ...

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 ...

The Food and Drug Administration has approved system changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin products. The system changes will go into effect ...

In a nod toward transgender inclusiveness, the FDA revised the iPLEDGE risk-modification program for isotretinoin by rewording the reproductive categories for patients. Beginning December 13, patients ...

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 ...

Doctors and their patients continue to face problems with a program designed to limit use of an acne medication that can cause birth defects if taken by pregnant women, a dermatology group said Monday ...

Please provide your email address to receive an email when new articles are posted on . Researchers, along with the American Academy of Dermatology, have organized an iPLEDGE Workgroup to advocate for ...