Simplifying the Generic Drug Application Process Act
Summary
Simplifying the Generic Drug Application Process Act This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug. Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.
Bill status
in committee
1 of 4 stages cleared
Introduction
Apr 2021
Committee Review
Floor Vote
President
Introduced Apr 29, 2021
Last action Apr 29, 2021
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Apr 29, 2021
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Apr 29, 2021
Introduced
Introduced in Senate
upper
1 primary · 1 co-sponsor
Sponsors
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