Faster Approval for Generic Drugs with New Safety Information
This act aims to speed up the market entry of safe generic drugs. It ensures that generic drugs are not delayed in approval even if their labels initially omit certain safety information protected by patent or exclusivity. This means citizens may gain quicker access to more affordable drug alternatives, potentially lowering healthcare costs.
Key points
Generic drugs can be approved faster, even if some patent-protected safety information is initially missing from their labels.
The FDA will still require the inclusion of necessary safety information to ensure safe drug use.
The act intends to increase the availability of more affordable generic medications in the market.
Introduced
Citizen Poll