The Food and Drug Administration Modernization Act of 1997
(FDAMA) Sec. 115 Clinical Investigations. (b) Women and Minorities. -- Section 505(b)(1) 21
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.
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.
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Labeling Guidance for Noncontraceptive Estrogen Drug Products for the
Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms -
Prescribing Information for Health Care Providers and Patient Labeling [Word]
or [PDF] (Posted 2/10/2004)
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on
Dosing and Labeling [HTML] or [Word] or [PDF]
(Issued 10/29/2004, Posted 10/29/2004)
Labeling Guidance for Noncontraceptive Estrogen Drug
Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal
Atrophy Symptoms - Prescribing Information for Health Care Providers and
Patient Labeling [Word]
Estrogen and Estrogen/Progestin Drug Products to Treat
Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms —
Recommendations for Clinical Evaluation [Word]
(Issued 1/2003, Posted 1/30/2003)
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Draft Guidance Documents:
Establishing Pregnancy Exposure Registries [Word]
(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
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.''
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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.
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.
September 12, 2000. Discussion of those products for
which improved pregnancy labeling is critical for effective prescribing
during pregnancy or proper counseling of pregnant women who have been
inadvertently exposed. Discussion on drug use during lactation and product
labeling on this issue.
March 28-29, 2000. 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
June 3, 1999. Discussion of possible changes to
pregnancy labeling as a result of the September 12, 1997, Part 15 public
hearing (see 62 FR 41061).
Meeting on Preclinical Assessment of Reproductive Toxicity Data, June 24, 1999 (Posted
6/2/1999). Includes the agenda and paper.
Subcommittee Meeting of the
Advisory Committee for Reproductive Health Drugs. Notice of meeting posted April 30,
Past Meetings for Assisted
September 29, 2003. Discussion of clinical trial
designs and outcome measures for drug products indicated for ovulation
induction and pregnancy in anovulatory, infertile women and development
of multiple follicles and pregnancy in ovulating women.
September 30, 2003. Discussion of NDA 21-322, Luveris (lutropin
alfa for injection), Serono, Inc., a recombinant human luteinizing
hormone drug product, proposed for concomitant administration with
recombinant human follicle stimulating hormone for the proposed
indication of induction of ovulation in infertile women with severe
luteinizing hormone and follicle stimulating hormone deficiency.
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FDA/Center for Drug Evaluation and Research
Last Updated: October 21, 2005
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