On May 11, the Senate Committee on Health, Education, Labor, and Pensions approved, 21-2, S. 934, the Food and Drug Administration Reauthorization Act, sponsored by Sen. Lamar Alexander (R-TN).
The bill would extend FDA’s authority to collect user fees on prescription brand and generic drugs, medical devices, and biosimilar products. Among other provisions, the legislation would require a public meeting to discuss “the impact of exclusion criteria on the enrollment in clinical trials of infants and children, [and] pregnant and lactating women.”
