HR 2101 · 114th Congress · Health

Research for All Act of 2015

Introduced 2015-04-29· Sponsored by Rep. Cooper, Jim [D-TN-5]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2015-05-01)

Plain Language Summary

[AI summary unavailable — showing source text] Research for All Act of 2015 This bill directs the Food and Drug Administration (FDA) to ensure that the clinical trials for products granted expedited approval to treat a serious or life-threatening condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis. This bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA, at the request of the drug sponsor, to facilitate development and expedite review of a new drug that is: intended to avoid serious adverse events or to treat a serious or life-threatening condition, intended for safer or more effective treatment for either men or women than a product approved to treat the general population or the other sex, and supported by results of clinical trials that separately examine outcomes for men and women. This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to ensure that, when appropriate, basic research projects include both male and female cells, tissues, or animals. In such projects, results must be disaggregated according to sex and sex differences must be examined and analyzed. NIH must update guidelines …

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (10)

9 Democrats1 Republican