Tag: generic drug approval
FDA's 180-Day Exclusivity: How It Helps First Generic Drug Makers Compete
The FDA's 180-day exclusivity gives the first generic drug maker a head start to challenge patents and bring down prices. But loopholes let companies delay launches-costing patients billions. Here's how it works-and why reform is coming.
Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications
The FDA uses priority and standard review timelines to speed up access to affordable generic drugs. Priority review, at 8 months, is reserved for first generics and drugs in shortage. A new pilot program rewards U.S. manufacturing, changing how companies approach approval.