Tag: ANDA requirements
- Dec 15, 2025
- SkyCaddie Fixer
- 10 Comments
Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence
Bioequivalence is the scientific standard the FDA uses to ensure generic drugs work just like brand-name versions. It’s not about ingredient amounts-it’s about how your body absorbs and uses the drug. Here’s how the 80-125% rule works and why generics are safe.