Distinguishing product and practice regulation in personalized medicine.

Distinguishing product and practice regulation in personalized medicine. Research Abstract Details 

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Distinguishing product and practice regulation in personalized medicine. Abstract Text:

B J Evans,

Protecting the public from faulty targeting of medicines, while preserving the crucial distinction between product and practice regulation, may require innovative regulatory approaches and close, ongoing involvement by the medical profession. This article explores four problem areas: validation of clinical claims for tests used in targeting therapies; developing and implementing appropriate restrictions on off-label use; promoting consistent concepts of clinical utility for use in various regulatory, reimbursement, and judicial contexts; and communication of clear information to guide clinicians in appropriate use of targeted therapeutic products. The article suggests an approach for addressing these problems by sharing regulatory activities between the Food and Drug Administration and a newly-created clinical standards board formed within the medical and scientific communities.

Distinguishing product and practice regulation in personalized medicine. Publishing Authors By Initials

BJ Evans,

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MEDLINE DATE:

Distinguishing product and practice regulation in personalized medicine. Journal Published:

PUBLICATION TYPE: Review

Journal: Clinical pharmacology and therapeutics

VOLUME: 81

Page Numbers: 288-93

Journal Abbreviation: Clin. Pharmacol. Ther.

ISSN: 0009-9236

DAY: 3

MONTH: Feb

YEAR: 2007

Distinguishing product and practice regulation in personalized medicine. Information

Number of References: 43

LANGUAGE: eng

NlmUniqueID: 372741

Distinguishing product and practice regulation in personalized medicine. Keywords Mesh Terms:

KEYWORDS: United States Food and Drug Administrati

MESH TERMS: standards

Chemical & Substance for Abstract: Distinguishing product and practice regulation in personalized medicine. Information

Substance Name: Pharmaceutical Preparations

Registry Number: 0

Grant and Affiliation Information for Distinguishing product and practice regulation in personalized medicine.

AFFILIATION: Program in Pharmacogenomics, Ethics, and Public Policy at the Indiana University Center for Bioethics, Indiana University Department of Medicine, Indianapolis, Indiana, USA. bjevans@iupui.edu

Country: United States

AGENCY: United States NIGMS

GRANT: U-01-GM61373

ACRONYM: GM

MEDLINETA: Clin Pharmacol Ther

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