E8-28169. Sex Differences in the Cardiovascular Device Trials; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Sex Differences in the Cardiovascular Device Trials.” FDA is co-sponsoring the conference with the Advanced Medical Technology Association (AdvaMed). The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the study and analysis of sex and gender differences in cardiovascular medical device trials, in anticipation of issuance of draft guidance on this subject.

DATES:

The workshop will be held on December 9, 2008, from 9 a.m. to 5 p.m. Participants are encouraged to arrive early to ensure time for parking and security screening before the meeting. Security screening will begin at 8 a.m. and reception will begin at 8:30 a.m. Please register by December 2, 2008, using the instructions in this document. Non-U.S. citizens are subject to additional security screening and should register as soon as possible.

ADDRESSES:

The workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT:

Kathryn O'Callaghan, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., rm. 230D, 240-276-4182, Rockville, MD 20850, [e-mail]; or

Ashley Boam, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., rm. 230J, 240-276-4188, Rockville, MD 20850, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

The purpose of the public workshop is to facilitate discussion between FDA and other interested parties on the study and analysis of sex and gender differences in cardiovascular medical device trials, in anticipation of issuance of draft guidance on this subject.

II. What Are the Topics We Intend to Address at the Public Workshop?

We hope to discuss a large number of issues at the public workshop, including, but not limited to:

• Current FDA perspective on sex/gender differences in pharmaceutical and medical device evaluation.
• Medical device development in the U.S. regulatory environment.
• Sex/gender-specific considerations in product design and clinical study design.
• The current state of cardiovascular treatment for women.
• Referral biases for women at risk for cardiovascular disease.
• The Clinical Research Organization and Institutional Review Board perspectives on inclusion, exclusion, recruitment, and retention issues related to women in clinical trials.
• The investigator/clinician perspective on the impact of sex/gender-specific issues on study design and conduct and available treatment options and limitations of use in women.
• The female patient perspective on enrollment and participation in clinical trials.
• The biostatistician perspective on statistical approaches and subgroup analysis in significant subpopulations.
• Case studies on gender-specific trials.

III. Is There a Fee and How Do I Register for the Public Workshop?

There is a modest fee to attend the conference to defray the costs of meals provided and other expenses. The fee for the meeting for registrants from industry is $125.00, and the fee for government registrants is $75.00. Fees will be waived for invited speakers and panelists. The registration process will be handled by AdvaMed, which has extensive experience in planning, executing, and organizing educational meetings. Register online at http://www.AdvaMed.org. Although the facility is spacious, registration will be on a first-come, first-served basis. Non-U.S. citizens are subject to additional security screening, and should register as soon as possible.

If you need special accommodations because of a disability, please contact Kathryn O'Callaghan at least 7 days before the public workshop.

IV. Where Can I Find Out More About This Public Workshop?

Background information on the public workshop, registration information, the agenda, information about lodging, and other relevant information will be posted, as it becomes available, on the Internet at http://www.AdvaMed.org and http://www.fda.gov/​cdrh/​dsma/​workshop.html.

Dated: November 19, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.