Tag: FDA generic approval
FDA Regulatory Authority: How the Agency Approves Generic Drugs
The FDA ensures generic drugs are as safe and effective as brand-name drugs through the ANDA pathway. With over 90% of U.S. prescriptions filled with generics, this system saves billions annually while maintaining strict scientific standards.
Read More- March 8, 2026
- Neil Hirsch
- 14 Comments
FDA Generic Approval Changes 2023-2025: What Manufacturers and Patients Need to Know
The FDA's 2023-2025 changes to generic drug approvals prioritize U.S. manufacturing to fix drug shortages. Learn how the ANDA pilot program works, which drugs are affected, and what it means for prices and availability.
Read More- December 31, 2025
- Neil Hirsch
- 13 Comments