Tag: generic drug approval

Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications
By Teddy Rankin, 18 Mar, 2026 / Medications

Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

The FDA uses priority and standard review timelines to speed up or manage generic drug approvals. Priority review cuts approval time from 10 to 8 months for first generics, shortage drugs, or improved formulations - and now includes incentives for U.S. manufacturing.

Hatch-Waxman Act: How Federal Law Shapes Generic Drug Approval
By Teddy Rankin, 13 Jan, 2026 / Medications

Hatch-Waxman Act: How Federal Law Shapes Generic Drug Approval

The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation and affordability. It enabled 90% of prescriptions to be filled with generics, saving $158 billion annually.