Bill Sponsor
Senate Bill 1462
117th Congress(2021-2022)
Simplifying the Generic Drug Application Process Act
Introduced
Introduced
Introduced in Senate on Apr 29, 2021
Overview
Text
Introduced
Apr 29, 2021
Latest Action
Apr 29, 2021
Origin Chamber
Senate
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
1462
Congress
117
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
Republican
Louisiana
Democrat
Minnesota
Senate Votes (0)
House Votes (0)
No Senate votes have been held for this bill.
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.

Text (1)
April 29, 2021
Actions (2)
04/29/2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
04/29/2021
Introduced in Senate
Public Record
Record Updated
Jan 11, 2023 1:49:05 PM