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Reportlinker Adds Personalized Medicine 2010: Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies
Date:6/29/2010

NIH Research Tools Policy

NIDDK model

FDA Pharmacogenetic approval for marketed drugs

EU Regulation

EMEA Pharmacogenomic submissions

EMEA Labeling and recommendations

EMEA Pharmacogenetic approval for marketed drugs

Japan Regulation

Global Personalized Medicine Harmonization: ICH

The Interdisciplinary Pharmacogenomic Review Group (IPRC)

Chapter 7 Personalized Medicine Ethical Issues

Informed consent

Electronic medical record standards

Adoption of electronic health records and healthcare IT (HIT)

Protection of medical records and privacy

Nuffield Council on Bioethics

Equitable distribution of benefits

Prevention of discrimination

Administration of personalized Medicine

Limited to wealthy individuals/markets

Race issues BiDiL

Lack of Asian and African Research

Cost of genotyping

Guidelines for genetic screening

National Society of Genetic Counselors Guidelines for genetic testing

NSGC Recommendations for protocols relating to predisposition genetic testing

Chapter 8 Personalized Medicine Legal and Reimbursement Issues

Intellectual Property Issues

US Patent and Tra
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