[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Notices]
[Page 49848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23996]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93D-0236]


Gender Studies in Product Development, Scientific Issues and 
Approaches; Notice of a Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
public workshop entitled ``Gender Studies in Product Development: 
Scientific Issues and Approaches'' is being held on November 6 and 7, 
1995. The workshop will focus on issues related to FDA's guideline 
entitled ``Guideline for the Study and Evaluation of Gender Differences 
in the Clinical Evaluation of Drugs.'' The guideline provides guidance 
on FDA's expectations regarding inclusion of both genders in drug 
development.

DATES: The public workshop will be held on November 6 and 7, 1995, from 
7:30 a.m. to 4 p.m.; an opportunity for public comment is planned on 
November 6, 1995, from 2:15 p.m. to 3:15 p.m. Interested persons should 
register by October 23, 1995. Attendance will be limited based on the 
availability of seating. Submit written notices of participation by 
October 23, 1995. Time may be limited depending on the number of 
participants scheduled to speak.

ADDRESSES: The public workshop will be held at Doubletree Hotel, 1750 
Rockville Pike, Rockville, MD 20852, 301-468-1100. Participants who 
wish to speak during the public comment session should request time by 
sending their name, affiliation, address, and phone number to John 
Sellman, Sociometrics, Inc., 8300 Colesville Rd., suite 550, Silver 
Spring, MD 20910, 301-608-2151, or FAX 301-608-3542. There is no 
registration fee, for this workshop. Those persons interested in 
attending the public workshop should mail their registration to 
Sociometrics, Inc. (address above). Copies of the transcript of the 
workshop summary will be available from the Freedom of Information 
Public Records and Documents Center (HFI-35), 5600 Fishers Lane, 
Rockville, MD 20057.

FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Office of External 
Affairs (HF-60), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3364.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 22, 1993 (58 
FR 39406), FDA published a notice on a guideline entitled ``Guideline 
for the Study and Evaluation on Gender Differences in the Clinical 
Evaluation of Drugs.'' The guideline discusses: Inclusion of patients 
of both genders in drug development; analyses of clinical data by 
gender; assessment of potential patient differences on the basis of 
gender, age, race, disease state, organ function, body size, genetic 
polymorphism and other characteristics that may affect responses to 
drugs, biologics or medical devices. The workshop will encourage an 
open scientific exchange in order to raise questions and issues related 
to the guideline.
    Optimal treatment of patients in some instances, may depend on an 
awareness of the effect of these characteristics so that suitable 
adjustments may be made in dosage amount and dosage schedules. 
Questions have arisen, however, regarding the clinical trials that are 
needed or that can be developed to carry out appropriate gender 
analysis and detect important clinical differences in gender related 
responses.
It is expected that by using gender as the model characteristic in this 
workshop, important information may be derived regarding patient 
characteristics that affect the safety and efficacy profile of medical 
products.

    Dated: September 19, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-23996 Filed 9-26-95; 8:45 am]
BILLING CODE 4160-01-F