Contraceptive guidelines in clinical trials

Exploratory IND Studies. Medical Devices — Frequently Asked Questions. Premarketing Risk Assessment. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Pharmacogenomic Data Submissions.

General Principles of Software Validation. Evaluation of Gender Differences in Clinical Investigations. Cooperative Research. Charging for Investigational Products. Recruiting Study Subjects. View Metrics. Jennifer E. Wiesenfeld, MD, CM 3,4. Access through your institution. Add or change institution. Limit characters. Limit 25 characters. Conflicts of Interest Disclosure Identify all potential conflicts of interest that might be relevant to your comment.

Err on the side of full disclosure. Yes, I have potential conflicts of interest. No, I do not have potential conflicts of interest. Limit characters or approximately words. The following information is required and must be completed in order to submit a comment:. Lyndsay Meyer For example, it recommends that clinical trial design for contraceptives should include women of all childbearing ages regardless of their weight, including those who are younger and older, and women who are obese.

The U. This draft guidance does not address development of contraceptive devices for this indication.