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Emerging Issues in Biotechnology Law

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Coursebook Papers:

Table of Contents

Collaborating with Academic Institutions (34 pp) $29.00
By Kathleen A. Denis, Ph.D.

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Corporate Partnerships (16 pp) $29.00
By Marya A. Postner, Ph.D.

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Public-Private Partnerships: Driving Product Development in Global Vaccines and Biodefense (22 pp) $29.00
By Frank M. Rapoport, Esquire

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Clinical Trials: Emerging Issues Regarding Globalization of Pharmaceutical Research, Insurance, Informed Consent, Securities Litigation, and Public Policy (28 pp) $29.00
By Michael Traynor, Esquire

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Avoiding Regulatory Exposure Related to Statements About Clinical Trials: A Primer for Biotechnology Companies on the FDA/SEC Collaboration (6 pp) $29.00
By Grail Walsh Sipes, Esquire

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Current Topics in FDA Regulation of Clinical Trials (14 pp) $29.00
By Grail Walsh Sipes, Esquire

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Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, No. 04-5350 (DC Cir., May 2, 2006)(opinion holding FDA cannot constitutionally prevent people from receiving investigational drugs) (58 pp) $39.00
By Professor Henry T. Greely

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Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, No. 04-5350 (DC Cir., en banc, August 7, 2007)(opinion holding FDA can constitutionally prevent people from receiving investigational drugs) (68 pp) $39.00
By Professor Henry T. Greely

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Investigations into Adverse Incidents During Clinical Trials of TGN 1412 (8 pp) $29.00
By Professor Henry T. Greely

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California Department of Health Guidelines for Human Stem Cell Research (20 pp) $29.00
By Professor Henry T. Greely

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Death Points to Risks in Research; One Woman's Experience in Gene Therapy Trial Highlights Weaknesses in the Patient Safety Net (8 pp) $29.00
By Professor Henry T. Greely

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Tougher Rules on Drug Trials Hit Research Medicine (4 pp) $29.00
By Professor Henry T. Greely

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Agency Moves to Rein In Medical Trials; Guidelines Address High-Risk Drugs in EU (4 pp) $29.00
By Professor Henry T. Greely

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Report of the Working Party of Statistical Issues in First-in-Man Studies (74 pp) $39.00
By Professor Henry T. Greely

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Follow-On Biologics: Intellectual Property and Regulatory Perspectives (16 pp) $29.00
By Kenneth J. Dow, Esquire

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Advanced Legal Concepts for a Fast Advancing Industry — A European Perspective on Some Emerging Issues (32 pp) $29.00
By Wolfgang A. Rehmann, Ph.D.

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Regulation of Genetic Testing: Federal Neglect (10 pp) $29.00
By Gail H. Javitt, Esquire

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Regulating (for the Benefit of) Future Persons: A Different Perspective on the FDA's Jurisdiction to Regulate Human Reproductive Cloning (32 pp) $29.00
By Gail H. Javitt, Esquire

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The FDA Response to Emerging Technology (10 pp) $29.00
By Ms. Mary K. Pendergast

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International Issues (9 pp) $29.00
By Erich F. Veitenheimer, Ph.D.

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