NIH Guide: FOOD AND DRUG ADMINISTRATION GUIDELINE FOR THE STUDY AND EVALUATIONOF GENDER DIFFERENCES IN THE CLINICAL EVALUATION OF DRUGS

FOOD AND DRUG ADMINISTRATION GUIDELINE FOR THE STUDY AND EVALUATIONOF GENDER DIFFERENCES IN THE CLINICAL EVALUATION OF DRUGS

NIH GUIDE, Volume 22, Number 31, August 27, 1993

P.T. 34

Keywords:

Pharmacology

Food and Drug Administration

The Food and Drug Administration (FDA) "Guideline for the Study and

Evaluation of Gender Differences in the Clinical Evaluation" was

published in the Federal Register as a Notice on July 22, 1993

(56FR39406). This guideline sets forth the expectations regarding

the inclusion of both genders in drug development and revises the

section "Women of Childbearing Potential" in the 1977 guideline

entitled, "General Consideration for the Clinical Evaluation of Drugs

[HEW Publication No. (FDA) 77-3040].

There are two major changes addressed in this guidance. First, the

FDA is withdrawing the restriction on the participation of women of

childbearing potential in early clinical trials, including clinical

pharmacology studies and early therapeutic studies. Second, FDA is

formalizing expectations regarding inclusion of subjects of both

genders in drug development; analyses of clinical data by gender;

assessment of potential pharmacokinetic differences between genders;

and, where appropriate, assessment of pharmacodynamic differences and

the conduct of specific additional studies in women.

A major effect of the new guideline is to give more flexibility to

IRBs, investigators, and subjects in determining how best to ensure

the safe participation of women of childbearing potential in clinical

studies. FDA policy in the new guideline reflects the importance of

the IRB deliberative process, the informed consent document and

process, and the necessity for attention to the completeness and

accuracy of information conveyed to potential and enrolled subjects.

Women must receive adequate information and opportunity for

discussion regarding, for example, potential risks to their fertility

and possible teratogenic potential of the drugs and biologics.

INQUIRIES

For futher information contact:

Patrick J. Savino

CDER Executive Secretariat Staff (HFD-8)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Telephone: (301) 594-1012

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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