0
ARTICLE |

FDA Lifts Ban on Women in Early Drug Tests, Will Require Companies to Look for Gender Differences

Paul Cotton
JAMA. 1993;269(16):2067. doi:10.1001/jama.1993.03500160029009.
Text Size: A A A
Published online

ABSTRACT

NEW POLICIES at the Food and Drug Administration (FDA) should substantially aid the understanding and advancement of women's health issues.

The date of the official announcement and policy change had not been set at press time. But Eileen Leonard, MD, of the agency's Center for Drug Evaluation and Research, confirms that the rule against including fertile women in early clinical trials, enacted in 1977, is being lifted.

"We are increasingly aware that there are approaches to ensuring the safety of the fetus other than completely excluding women of childbearing potential," says Leonard. Other precautions can be taken, such as informing women of the risks, ensuring that they practice contraception, doing pre-enrollment pregnancy testing, and the like, she says.

'Other Players'  "Also, we recognize that there are other players in clinical trials who should have a say in that decision. Clearly the women, the investigators, and IRBs [institutional review boards] should

Topics

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

Figures

Tables

References

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Jobs
brightcove.createExperiences();