SENATE 775118th CongressRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Increasing Transparency in Generic Drug Applications Act

Last Action: 3/14/2023

Actions

2023-03-14Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2023-03-14Introduced in Senate

CRS Summary

As of 2023-03-14 (00)

Increasing Transparency in Generic Drug Applications Act

This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.

Cosponsors (3)

Rand Paul (R-KY)
Mike Braun (R-IN)
John Hickenlooper (D-CO)

Subjects

Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Prescription drugs

Read on Congress.gov

Sourced from Congress.gov (public domain).

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.