HR 4879 · 113th Congress · Health

Research for All Act of 2014

Introduced 2014-06-17· 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.(2014-06-20)

Plain Language Summary

[AI summary unavailable — showing source text] Research for All Act of 2014 - Directs the Food and Drug Administration (FDA) to review and develop policies to ensure that the design and size of clinical trials for products granted expedited approval to treat a serious or life-threatening disease or condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis. Amends the Federal Food, Drug, and Cosmetic Act to require FDA, at the request of the sponsor of a new drug, to facilitate the development and expedite its review if the drug is: intended to avoid serious adverse events or to treat a serious or life-threatening disease or condition, intended for safer or more effective treatment for either men or women than a currently available product approved to treat the general population or the other sex, and supported by results of clinical trials that include and separately examine outcomes for men and women. Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to determine when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or anima…

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

Cosponsors (13)

11 Democrats2 Republicans