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Conditional Approval Act

10/28/2022, 1:46 AM

Congressional Summary of HR 5497

Conditional Approval Act

This bill authorizes the Food and Drug Administration to conditionally approve certain new drugs intended for diseases that are seriously debilitating, life threatening, or chronic, and for which meaningful treatments do not exist. The bill also limits liability related to these conditionally approved drugs.

Current Status of Bill HR 5497

Bill HR 5497 is currently in the status of Bill Introduced since December 19, 2019. Bill HR 5497 was introduced during Congress 116 and was introduced to the House on December 19, 2019.  Bill HR 5497's most recent activity was Referred to the Subcommittee on Health. as of December 20, 2019

Bipartisan Support of Bill HR 5497

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
2
Democrat Cosponsors
0
Republican Cosponsors
2
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 5497

Primary Policy Focus

Health

Potential Impact Areas

- Civil actions and liability
- Drug safety, medical device, and laboratory regulation
- Health care coverage and access
- Health information and medical records
- Marketing and advertising
- Medical research

Alternate Title(s) of Bill HR 5497

Conditional Approval Act
To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs, and for other purposes.
Conditional Approval Act

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