Latest Update: Friday, January, 16th 2009

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 9/25/2008--Passed House amended.    (There is 1 other summary) Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.Directs the Secretary to require that a new drug application include any clinical data possessed by the applicant that relates to the safety and effectiveness of the drug involved by gender, age, and racial subgroup. (Currently, this is required by regulation.)Requires the Secretary to develop guidance for the staff of the Food and Drug Administration (FDA) [...]

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Latest Actions
  • 09/26/2008 - Received in the Senate.
  • 09/25/2008 - Considered as unfinished business. (consideration: CR H9927)
  • 09/25/2008 - On motion to suspend the rules and pass the bill, as amended Agreed to by recorded vote (2/3 required): 418 - 4 (Roll no. 642). (text: CR 9/23/2008 H8689)
  • 09/25/2008 - Motion to reconsider laid on the table Agreed to without objection.
  • 09/23/2008 - Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-874.

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