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1998 regulation Accounting addition agency allow Appendix approved body clinical drug trials clinical trials Coding collected Comments comparison group compliance conducted criteria data by sex demographic demonstrate detect determine differences in drug Drug Administration drug applications drug development early effective ensure Estimates evaluate evidence example FDA's medical officers findings Food and Drug Gender guidance important Improvement included inclusion of women increased IND annual reports IND applications initial Institute Integrated Summary issues less levels Medical Officer Reviews men and women monitor NDAs number of women outcome data Overall participating in clinical percent percentage pharmacokinetics Phase population potential presentation recently recommended regulatory requirements relevant represented Research risk safety and efficacy sample sex differences sex-related analyses specific sponsors standardized statistically significant study participants submitted to FDA subsequent summary documents Table tabulation taking treatment weight women in clinical Women's Health
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 - 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Page 1 - Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women (GAO-01-286R, January 23, 2001).