Pipeline · Bill → Law
Step 1
Introduced
Feb 17, 2023
Step 2
Referred
Feb 24, 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 consider relevant patient experience data in the risk-benefit assessment framework used in the process for approving new drugs. After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework.
Timeline · 3 actions
Feb 24, 2023
Referred to the Subcommittee on Health.
Feb 17, 2023
Introduced in House
Feb 17, 2023
Referred to the House Committee on Energy and Commerce.