HR. 1051In Committee
To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Allows FDA approval of certain later-filed generic drug applications when a first filer does not begin commercial marketing within the required timeframe
Plain-English overview
What this bill does
Allows FDA approval of certain later-filed generic drug applications when a first filer does not begin commercial marketing within the required timeframe
Key points
- Require marketing within 75 days
- Authorize subsequent generic approvals
- Revoke eligibility
Current status
Where it stands
Status
In Committee
Latest action
2025-02-06 — Referred to the House Committee on Energy and Commerce.
Related context
Topics and policy areas
undefinedDrug safety, medical device, and laboratory regulationHealthPrescription drugs