Tag: generic drug approval

Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence

Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence

Learn how the FDA proves generic drugs work just like brand-name ones using bioequivalence studies, the 80-125% rule, and strict testing standards to ensure safety and effectiveness.

Read More
How Long Does the FDA Take to Approve Generic Drugs? 2025 Timelines Explained

How Long Does the FDA Take to Approve Generic Drugs? 2025 Timelines Explained

Learn the real FDA approval timeline for generic drugs in 2025, including standard vs. priority review times, AI-driven speed-ups, and why some applications take over a year. Get the facts behind affordable medications.

Read More