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 FDA has issued a notification to isotretinoin manufacturers to modify the iPledge Risk Evaluation and ...

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 . Patients may now take pregnancy tests outside of a medical setting during and after treatment. If a patient does ...

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 ...

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 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 ...

WASHINGTON - Dermatologists are renewing their concerns that efforts to keep pregnant women from using a drug that can cause birth defects may also keep it from patients who need it for severe acne.

Virtually no one opposes the goal of the mandatory new federal program governing the use of Accutane: to prevent pregnant women from taking the potent acne drug, approved in 1982, because it causes ...

Add Yahoo as a preferred source to see more of our stories on Google. By Andrew M. Seaman NEW YORK (Reuters Health) - Women using a popular acne drug that causes birth defects need better information ...

Dermatologists are renewing their concerns that efforts to prevent pregnant women from using a drug that can cause birth defects may also keep the drug from patients who need it for severe acne. The ...

Dermatologists are renewing their concerns that efforts to prevent pregnant women from using a drug that can cause birth defects may also keep the drug from patients who need it for severe acne. The ...