Women's Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement : Report to Congressional Requesters

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Page 11 - ... and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such...
Page 11 - The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions...
Page 11 - Drugs17 recommended that clinical drug trials should, in general, reflect the population that will receive the drug when it is marketed.
Page 7 - Exploring the Biological Contributions to Human Health: Does Sex Matter?
Page 32 - The Agency provided technical comments directly to your staff. We appreciate the opportunity to review and comment on this draft report...
Page 32 - Women's Health: Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement (GAO-01-754).
Page 5 - ... and provided false or questionable return addresses. It is notable that we identified these numerous problems despite the relatively small number of drugs we purchased, consistent with problems recently identified by state and federal regulatory agencies. Agency and External Comments In commenting on a draft of this report, FDA generally agreed with our findings and conclusions and made suggestions to clarify or expand upon its contents (see app. II). FDA commented that, while the draft report...
Page 36 - Health: NIH Has Increased Its Efforts to Include Women in Research, GAO/HEHS-00-96.
Page 1 - Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women (GAO-01-286R, January 23, 2001).
Page 4 - FDA has not effectively overseen the presentation and analysis of data related to sex differences in drug development.

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