Tag: generic drug approval
How FDA Approval Costs for Generics Impact Drug Prices and Patient Access
FDA approval costs for generic drugs are rising, delaying access and increasing patient expenses. Learn how GDUFA fees, reformulation delays, and regulatory policies impact drug prices and healthcare savings.
Read More- December 6, 2025
- Neil Hirsch
- 15 Comments
How Long Does the FDA Take to Approve Generic Drugs? 2025 Timelines Explained
The FDA's generic drug approval timeline averages 10 months, but simple generics can be approved in under 40 days. Complex drugs take longer. AI, priority reviews, and new programs are speeding things up - here's how.
Read More- December 1, 2025
- Neil Hirsch
- 9 Comments