S. 4446 · 117th Congress
Modernizing the Accelerated Approval Pathway Act of 2022
- Stage
- In committee
- Sponsor
- Susan Collins
- Introduced
- 2022-06-22
- Latest action
- 2022-06-22 · Introduced in Senate
Summary
Modernizing the Accelerated Approval Pathway Act of 2022
This bill modifies provisions relating to the accelerated approval of drugs for serious or life-threatening diseases or conditions, including by requiring the Food and Drug Administration (FDA) to publish its reasons when it determines a postapproval study to be unnecessary. The bill also establishes a pilot program and an FDA council to support the development of drugs for rare diseases and ensure the appropriate use of the accelerated approval pathway, respectively.