[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]
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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.
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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
