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The Food and Drug Administration Modernization Act of 1997
(FDAMA) Sec. 115 Clinical Investigations. (b) Women and Minorities. -- Section 505(b)(1) 21
U.S.C.
355 (b)(1) was amended by adding the words in bold:
"The Secretary shall, in consultation with the Director of the
National Institutes of Health and the representatives of the drug manufacturing industry,
review and develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).
Historically, women have been neglected in clinical trials for new drugs,
devices, and biological products. To address these and other issues, FDA created the
Office of Women's Health. CDER strongly
supports activities on women's health issues through the Women's
Health Subcommittee of the CDER Medical Policy Coordinating Committee.
By encouraging diversity at all stages of a drug's development, FDA hopes
that drug sponsors will better understand how a drug will affect the different populations
once it is marketed. The Agency believes it must identify important information about a
drug during the investigational phase, such as dosages for different age groups, genders,
and racial subgroups, and to use that information to refine labeling information, patient
selection, and dose selection.
This web site bring together regulations, guidance documents, and related
information to assist FDA and drug developers in correcting any identified gender
disparities in drug, device, and biologics testing and regulation policy.
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Code Of Federal Regulations (CFR). The final regulations
published in the Federal
Register (daily published record of proposed rules, final rules, meeting notices,
etc.) are collected in the CFR. The CFR is divided into 50 titles
which represent broad areas subject to Federal regulations. The FDA's portion of the
CFR interprets the Federal
Food, Drug and Cosmetic Act and related statutes. Section 21 of the CFR
contains most regulations pertaining to food and drugs. The regulations document all
actions of all drug sponsors that are required under Federal law.
Code of Federal
Regulations Final Rules:
21 CFR Parts 312 and
314 [Docket No. 95N-0010] February 11, 1998. Investigational New Drug Applications
and New Drug Applications. FDA
amended its regulations pertaining to new drug applications (NDA's) to require
effectiveness and safety data for important demographic subgroups, specifically gender,
age, and racial subgroups.
21
CFR Part 314.101. Applications for FDA Approval to Market a New Drug.
Within 60 days after FDA receives an application, the Agency determines whether the
application is complete enough to review.
21 CFR Part 312. [Docket No. 97N-0030].
June 1, 2000. Final Rule. Investigational New Drug Applications; Amendment to
Clinical Hold Regulations for Products Intended for Life-Threatening Diseases. This
final rule amends investigational new drug applications (IND's) to permit FDA to place a
clinical hold on one or more studies under an IND involving a drug that is intended to
treat a life-threatening disease. The amendment permits the Agency to place a clinical hold if men or women
with reproductive potential are excluded from participation in an investigation only
because of a risk or potential risk of reproductive or developmental toxicity from use of
the investigational drug.
A related FDA Talk Paper entitled FDA Proposes Rule on Women in
Clinical Trials provides more background information on this amendment.
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Guidance documents represent the Agency's current thinking on a
particular subject. These documents are prepared for FDA review staff and drug sponsors to
provide guidelines for the processing, content, and evaluation/approval of applications,
and also for the design, production, manufacturing, and testing of regulated products.
They also provide consistency in the Agency's regulation, inspection and
enforcement procedures. Because guidances are not regulations or laws, they are not
enforceable. An alternative approach may be used if it satisfies the requirements of
the applicable statute, regulations, or both.
Guidance Documents
FDA News
Releases
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Draft Guidance Documents:
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Establishing Pregnancy Exposure Registries [Word]
or [PDF]
(Issued 8/2002, Posted 9/20/2002). This guidance provides sponsors with
advice on how to establish pregnancy exposure registries to monitor the
outcomes of pregnancies for women who were exposed to specific medical
products, including drugs and biological products (including vaccines).
The ultimate goal of pregnancy exposure registries is to provide
clinically relevant human data that can be used in a product’s
labeling to provide medical care providers with useful information for
treating or counseling patients who are pregnant or anticipating
pregnancy.
Reviewer
Guidance: Evaluation of Human Pregnancy Outcome Data. (6/2/1999) This guidance provides reviewers with a standard
approach to the assessment of potential risks related to exposures of pregnant women to
drugs and biological products. Docket No. 99D-1540, June
4, 1999 requests comments on the draft guidance for reviewers entitled
``Evaluation of Human Pregnancy Outcome Data.''
Establishing
Pregnancy Registries.
(6/2/1999). A pregnancy registry is a systematic epidemiology
study that involves collecting and assessing postmarketing data on the
potential for adverse health effects to the mother, fetus, and/or infant
from exposure to drugs during pregnancy. Docket No. 99D-1541 requests
comments on the draft guidance for Industry on Establishing Pregnancy
Registries.
Dockets
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Past Meetings
Clinical
Pharmacology During Pregnancy; Public Meeting. This meeting summarized the
state of knowledge on clinical pharmacology in pregnancy, raised awareness among clinician
researchers and leaders about the need for clinical research and collaboration in this
area, and garnered support for such research from health advocacy groups and others.
Dates: Monday and Tuesday, December 4 and 5, 2000, from 8 a.m. to 5 p.m.
Dietary Supplement
Use During Pregnancy - March 30, 2000. This web page provides links to the Federal
Register announcement of the meeting, questions to be addressed, and an agenda.
Advisory Committee for
Reproductive Health Drugs, Pregnancy Labeling Subcommittee. March 28,
2000, from 9 a.m. to 5 p.m. and on March 29, 2000, from 8 a.m. to 5 p.m.
Presentations and discussions will include the status of proposed pregnancy labeling
changes, the status of activities related to preclinical assessment of reproductive
toxicity, the FDA draft guidance entitled, A Guidance for Industry, Establishing Pregnancy
Registries, and strategies for monitoring drug risks in pregnant
women.
FDA/Industry
Meeting on Preclinical Assessment of Reproductive Toxicity Data, June 24, 1999 (Posted
6/2/1999). Includes the agenda and paper.
Hearing on Content and Format of Labeling
for Human Prescription Drugs. Posted July 31, 1997.
Subcommittee Meeting of the
Advisory Committee for Reproductive Health Drugs. Notice of meeting posted April 30,
1999.
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Outreach Notebook for
the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical
Research. This publication is intended to
help investigators understand and comply with the NIH's inclusion policies.
Deadly Diseases and People of Color: Are Clinical Trials an Option?
Howard University, Washington, DC,
October 25, 1996
University of Miami, School of
Medicine, Miami, FL, May 5, 1997
National Action Plan on Breast Cancer.
The NAPBC, a public/private partnership, is coordinated by the Public Health
Service Office on Women's Health, Department of Health and Human Services.
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FDA/Center for Drug Evaluation and Research
Last Updated: October 30, 2003
Originator: OTCOM/DML
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