Generic Approval Timelines: How Long FDA Reviews Take
FDA generic drug approval timelines vary from weeks to years, depending on drug complexity and application quality. Learn how the 10-month standard review works, what speeds it up, and why some approvals take over a year.
Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence
Learn how the FDA ensures generic drugs work the same as brand-name ones through bioequivalence testing. Understand the 80-125% rule, what it really means, and why generics are safe and effective.
Hatch-Waxman Act: How Federal Law Shapes Generic Drug Approval in the U.S.
The Hatch-Waxman Act created the legal framework for generic drug approval in the U.S., saving billions in healthcare costs. Learn how ANDAs, the Orange Book, and patent challenges make generics possible.