HR. 843In Committee
Prompt Approval of Safe Generic Drugs Act
Authorize FDA approval of certain generic drugs with labeling that omits patent- or exclusivity-protected safety information while still requiring safety information needed for safe use
Plain-English overview
What this bill does
Authorize FDA approval of certain generic drugs with labeling that omits patent- or exclusivity-protected safety information while still requiring safety information needed for safe use
Key points
- Require necessary safety labeling
- Authorize generic drug approval
- Allow omitted protected labeling
Current status
Where it stands
Status
In Committee
Latest action
2025-01-31 — Referred to the House Committee on Energy and Commerce.
Related context
Topics and policy areas
undefinedDrug safety, medical device, and laboratory regulationHealthMarketing and advertising