Patient Involvement With Life Threatening Diseases
"Respect for Patients' autonomy
is now considered
Fundamental to the practice of medicine."
Norman J. Levinsky, M.D.
New England Journal of Medicine
February 22, 1996
Patient Representatives
- Patient Representative Program,
The Patient Representative is responsible for providing the Food and Drug
Administration (FDA) and the advisory committee the unique perspective of
patients and family members directly affected by a serious or life-threatening
disease. (September 13, 2001)
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When a Patient Speaks ... Patient
Representatives to FDA Advisory Committees, March 30, 1998
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The Value of Patient's
Perspective in the FDA Decision Process, Sharon Smith Holston, Deputy
Commissioner, FDA, November 3, 1997
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FDA Advisory Committees,
FDA Dockets - information about contacts, background, transcripts and the
Federal Advisory Committee Act
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Getting Outside
Advice for "Close Calls", by Dixie Farley, FDA Consumer Special
Report on New Drug Development in the United States, January 1995
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Cancer Patient Representative
Nomination Package, current as of April 18, 2001
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Patient Representative
for the Antiviral Drugs Advisory Committee, current as of April 18, 2001
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Guidelines for Speakers at the Open
Public Hearing of an FDA Advisory Committee Meeting
Investigational Products
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Participation
of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling:
A Review of New Molecular Entities Approved 1995-1999, Brenda Evelyn, Office
of Special Health Issues, October 16, 2001.
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Women's
Participation in Clinical Trials and Gender-Related Labeling:
A Review of New Molecular Entities Approved 1995-1999, Brenda Evelyn, Office
of Special Health Issues, June 2001.
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Draft Guidance for Industry - Information Program on Clinical
Trials for Serious or Life-Threatening Disease; implementation Plan, June
2001, This is the second draft guidance document intended to assist companies
when submitting clinical trial information to the Clinical Trials Data Bank
as required by Section 113 of the Food and Drug Administration Modernization
Action of 1997 (FDAMA) Text Version
, PDF Version Federal
Register Notice, July 9, 2001 Text
Version , PDF Version
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Why Should
FDA Regulate Drugs?, An Interview with Janet Woodcock, M.D., Director
of FDA's Center for Drug Evaluation and Research, by Tamar Nordenberg, FDA
Consumer Magazine, September-October 1997
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Understanding Clinical
Trials From The Patient's Perspective, by Patty Delaney, Coping, May/June
1997
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The FDA - What Does It
Do For Cancer Patients?, by Patty Delaney, Coping, September/October
1997
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Clinical Trials of Medical
Treatments: Why Volunteer? (FDA 98-1294)
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The Truth About Choosing Medical Treatments (FDA 00-1248)
[382K PDF file]
[HTML file]
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Thalidomide Information Page,
FDA/CDER information about thalidomide
-
Thalidomide:
Potential Benefits and Risks, an open public scientific workshop, September
9-10, 1997, Natcher Conference Center, National Institutes of Health, Bethesda,
Maryland
Executive Summary
Transcript for September 9, 1997, (approximately
140 pages)
Transcript for September 10, 1997 (approximately
100 pages)
-
Giving Thalidomide
a Second Chance, by Herbert Burkholz, FDA Consumer, September-October
1997
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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
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Treatment IND definition and discussion
-
Treatment INDs which were allowed
to proceed, updated September 24, 1999 (current as of April 18, 2001)
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Demographic Subgroups, Federal Register
notice to amend regulations for NDAs to clearly define in NDA format
and content regulations the requirement to present effectiveness and safety
data for important demographic subgroups, specifically gender, age, and
racial subgroups, February 11, 1998.
Related Information
-
National Institutes of Health Clinical Trials Database
http://clinicaltrials.gov
-
The MedWatch Program
is to enhance the effectiveness of postmarketing surveillance of medical
products as they are used in clinical practice and to rapidly identify significant
health hazards associated with these products. Visit the MedWatch
page and learn how to work with your health care professional to report
possible adverse reactions. The patients identity is kept confidential.
This section also contains extensive information about the safety of medical
products, with summaries of safety-related labeling changes presented on
a month-by-month basis.
-
Cancer Liaison Program Index
-
HIV/AIDS Program Index
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Consumer Drug Information,
CDER, consumer drug information sheets which provide basic information about
medications recently approved by the FDA.
- Food & Drug Interactions,
Many medicines have powerful ingredients that interact, and diet and lifestyle
can sometimes have a significant impact on a drug's ability to work in the
body. Certain foods, beverages, alcohol, caffeine can interact with
medicines. This brochure (in PDF format) has information about possible
interactions between many common prescription and nonprescription (over-the-counter)
drugs with food, alcohol and caffeine. National Consumers League, 1998.
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National Women's Health Information
Center (NWHIC) the governments focal point for women's health issues.
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Consumer Health Page,
Agency for Healthcare Research and Quality (AHRQ)
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Your Guide
to Quality Health Care, was developed to help you make health care decisions
using information about quality. The Guide is based on research about the
information people want and need when choosing health plans, doctors, treatments,
hospitals, and long-term care. These are the major decisions most people
face at one time or another during their liveseither for themselves
or for a loved one, Agency for Healthcare Research and Quality (AHRQ).
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MEDLINEplus,
information pages designed to direct you to resources containing information
that will help you research your health questions.