Pipeline · Bill → Law
Step 1
Introduced
Jun 6, 2023
Step 2
Referred
Jun 9, 2023
E&C
Step 3
Committee
Step 4
House floor
Step 5
Senate
Step 6
Resolve Changes
Step 7
Signed
SummaryCRS Summary
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.
Timeline · 3 actions
Jun 9, 2023
Referred to the Subcommittee on Health.
Jun 6, 2023
Introduced in House
Jun 6, 2023
Referred to the House Committee on Energy and Commerce.