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- Click on highlighted document title to display the document in its entirety. Items are shown in order of aquisition.
- Medical Verses Scientific Clinical research: Time for an Immediate Change!
October, 2006 commentary by Stephen L. DeFelice M.D.
The Mass Media: An Unwitting Enemy of the patient
December 25, 2005 commentary by Stephen L. DeFelice M.D.
The Nutraceutical Revolution: The Hidden Medical Miracles in Everyday Foods
Reprinted from Mother Earth News
January 12, 2006
- The Doctornaut Act
A Proposal by FIM, the Foundation for Innovation in Medicine to Accelerate medical Discovery
October 1, 2003
Bioterrorism: The Potential Role of L-Acetylcarnitine in the Treatment of Sepsis and Septic Shock
March 13, 2003 commentary by Stephen L. DeFelice M.D.
Slowing Down or Reversing the Aging Process
March 13, 2003 commentary by Stephen L. DeFelice, M.D.
The Promise of the Combination of Adriamycin and Carnitine For the Treatment of Cancer
October 23, 2002 commentary by Stephen L. DeFelice, M.D.
Doctornauts, Physician Volunteers for Clinical research: The Time Has Come for Congress to Act
July 4, 2002 commentary by Stephen L. DeFelice, M.D.
The Moral Dilemma of Embryonic Stem and Fetal Cell research: A Proposed Solution
June 2002 commentary by Stephen L. DeFelice, M.D.
The Nature of the Nutraceutical Revolution in the Year 2000
January 1, 2000 commentary by Stephen L. DeFelice, M.D.
The Dietary Supplements, Special Foods and Diets Dilemma
What Should We Do?
By Stephen L. DeFelice, M.D.
Op-Ed article from The SanFrancisco
Chronicle
By Stephen L. DeFelice, M.D.
Clinical Research &
Nutraceutical Trademarks
December 20, 1999 commentary by Stephen L. DeFelice, M.D.
Press Release: New FDA
Regulations January 6th Willl Be Analyzed at FIM's February 3rd
/4th Nutraceutical Conference
January 7, 2000
Time to Correct the Epistemologic
Chaos That Prevents Nutraceutical Clinical Discovery
October 12, 1999 commentary by Stephen L. DeFelice, M.D.
Bill H.R.3001 - The Nutraceutical
Research and Education Act
Oct. 1, 1999 (introduced to Congress)
This bill is to amend the Federal Food, Drug, and Cosmetic Act
to promote clinical research and development on dietary supplements
and foods for their health benefits; to establish a new legal
classification for dietary supplements and foods with health
benefits, and for other purposes.
FIM Rationale And Proposed Guidelines For The Nutraceutical Research & Education Act - NREA
Nov. 10, 2002
By Stephen L. DeFelice, M.D.
Presented at FIM's 10th Nutraceutical Conference: Nutraceuticals & Pharmaceuticals Taken Together: A New Health Sector. Plus: A New FIM Congressional Proposal: The Nutraceutical Research & Education Act - NREA
NEWS ADVISORY
Oct. 30, 2002
FDA announced it intends to seize cholesterol lowering Benecol
margarine and ban it as a dietary supplement.
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- FIM's Principles
for Sufficient Evidence for Nutraceutical (Medical-Health) Claims
Because of the absence of guidelines regarding what is sufficient
evidence for making claims FIM has proposed principles which
are acceptable to most authorities and should be adopted by corporations
as a guideline to making claims. Dr. DeFelice believes there
is little or no difference between a health and medical claim.
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- FIM's Response
to the FDA Advanced Notice of Proposed Rulemaking (ANPR) on Medical
Foods
- April 10, 1997
In a letter to Dr. Yetley of the FDA Dr. DeFelice applauds certain
aspects of the ANPR but also strongly warns that certain proposals
contained therein will have a powerful negative impact on nutraceutical
research.
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- FIM's Response
to the Draft Document of the President's Commission on Dietary
Supplement Labels Regarding Dietary Supplements (DSHEA)
July 24, 1997
In a letter to Dr. Fisher, Executive Director, Commission on
Dietary Supplement Labels, Dr. DeFelice proposes ways in which
to improve DSHEA which involve two issues -- a. the need to correctly
disseminate truthful medical - health claims and b. the need
to encourage research to generate the data to support the medical
- health claims.
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- The Need
For a Research-Intensive Nutraceutical Industry:
What Can Congress Do?
(The Claims-Research Connection)
A FIM Proposal - July 1996
The cardinal principle of FIM is that nutraceutical research
can only thrive if our system reasonably permits institutions,
particularly corporations, to make medical-health claims based
on preclinical - clinical research.
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- What Is a True
Nutraceutical?
-and-
What Is the Nature & Size of the U.S. Nutraceutical Market?
A press release dated March 1994
Stephen L. DeFelice, M.D.
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- Nutraceuticals
- Opportunities In An Emerging Market
Stephen L. DeFelice, M.D., Scrip Magazine, September 1992
Dr. DeFelice believed and still believes that the first prototype
nutraceutical company has not yet been born. In this article
he discusses the nature of the market and ways to approach it.
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- Conference
Summary
The Nutraceutical Revolution: Where Do We Go From Here?
August 1990
In this conference it was concluded that there was an urgent
need to modify our system in order to encourage nutraceutical
research.
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- Proceedings
of the Symposium:
A Comparison of the U.S., European & Japanese Nutraceutical
Health and Medical Claim Rules
Published in Regulatory Affairs, Vol. 5, Summer 1993
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- The NutraCeutical
Revolution: Fueling a Powerful, New International Market
1989
Stephen L. DeFelice, M.D.
Presented at the Harvard University Advanced Program in Biomedical
Research Management and Development in Italy, jointly organized
by Harvard University Biomedical Management Faculty and Farmindustria,
Associazione Nazionale dell'Industtia Farmaceutica, with the
collaboration of The Foundation for Innovation in Medicine, March
1989, at Villa Olmo, Como, Italy.
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- The Promise and
Problems of Natural Substances in Medicine
- This volume represents the findings of a symposium held at
Columbia University on May 17, 1983. It is the first of a series
of symposia which will dealt with the state of the innovative
process in medicine.
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THE FOUNDATION FOR INNOVATION IN MEDICINE
411 North Avenue East
Cranford, New Jersey 07016
(908) 272-2967 Fax: (908) 272-4583
E-mail: fimdefelice@aol.com
(© 2004 The Foundation For Innovation In Medicine. All rights reserved.)
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