Tag: FDA
REMS for Isotretinoin: iPLEDGE Requirements and Safety in 2026
The iPLEDGE program is a strict FDA safety system to prevent birth defects from isotretinoin. Learn how the 2023 updates changed pregnancy testing, birth control rules, and prescription access - and what you need to know if you're prescribed this powerful acne treatment.
How Different Countries Regulate NTI Generics: A Global Comparison
NTI generics require stricter regulation than regular generics due to their narrow safety margin. This article compares how the FDA, EMA, Canada, Japan, and others ensure safety and efficacy, highlighting global standards, market trends, and future regulatory shifts.