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Clinical Research Practices and Drug Regulatory Affairs
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Volume 2, Issue 2

Clinical Research and Regulatory Affairs

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Clinical Research and Regulatory Affairs, Volume 2, Issue 2 (1984)

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Clinical Research Practices and Drug Regulatory Affairs, Volume 2, Issue 2 (1984)

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Article

Introduction to Symposium

Max Link

Pages: 77-82

Published online: 28 Sep 2008

First Page PreviewforIntroduction to Symposium | PDF (213 KB)

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Article

The Role of Fda's Orphan Products Development Program in the Facilitation of Development of orphan drugs and other Products; Implementation of the Orphan Drug act

Marion J. Finkel

Pages: 83-96

Published online: 28 Sep 2008

First Page PreviewforThe Role of Fda's Orphan Products Development Program in the Facilitation of Development of orphan drugs and other Products; Implementation of the Orphan Drug act | PDF (466.4 KB)

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Article

The Future Goals of the PMA Commission on Drugs for Rare Diseases

Lewis H. Sarett

Pages: 97-107

Published online: 28 Sep 2008

First Page PreviewforThe Future Goals of the PMA Commission on Drugs for Rare Diseases | PDF (434.6 KB)

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Article

The National Orphan Drugs and Devices Foundation

Joel A. Bennett

Pages: 109-115

Published online: 28 Sep 2008

First Page PreviewforThe National Orphan Drugs and Devices Foundation | PDF (246.3 KB)

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Article

The Congress' Expectation of Private Sector Activities Resulting from the Orphan Drug Act

Senator Orrin G. Hatch

Pages: 117-123

Published online: 28 Sep 2008

First Page PreviewforThe Congress' Expectation of Private Sector Activities Resulting from the Orphan Drug Act | PDF (269.3 KB)

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Article

The Future Goals of the Gpia's Institute for Orphan Drugs

William F. Haddad

Pages: 125-129

Published online: 28 Sep 2008

First Page PreviewforThe Future Goals of the Gpia's Institute for Orphan Drugs | PDF (190 KB)

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Article

The Accomplishments of the Orphan Products Board and Its Future Goals

Glenna M. Crooks

Pages: 131-137

Published online: 28 Sep 2008

First Page PreviewforThe Accomplishments of the Orphan Products Board and Its Future Goals | PDF (268.1 KB)

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Article

Fda's Role in the Facilitation of Development of Medical Foods for Rare Conditions: Interactions with Industry

John E. Vanderveen

Pages: 139-151

Published online: 28 Sep 2008

First Page PreviewforFda's Role in the Facilitation of Development of Medical Foods for Rare Conditions: Interactions with Industry | References | PDF (444.6 KB)

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Article

The Future of the Orphan Drug Act

Congressman Henry Waxman

Pages: 153-160

Published online: 28 Sep 2008

First Page PreviewforThe Future of the Orphan Drug Act | PDF (301.6 KB)

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Article

The Consumer's View of Orphan Drugs

Abbey S. Meyers

Pages: 161-164

Published online: 28 Sep 2008

First Page PreviewforThe Consumer's View of Orphan Drugs | PDF (141.2 KB)

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Article

The Academic Scientist's View of Orphan Drugs

Melvin H. Van Woert

Pages: 165-167

Published online: 28 Sep 2008

First Page PreviewforThe Academic Scientist's View of Orphan Drugs | PDF (96.6 KB)

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Article

Research Requirements and Criteria for Marketing Approval of Orphan Drugs - FDA View

Solomon Sobel

Pages: 169-177

Published online: 28 Sep 2008

First Page PreviewforResearch Requirements and Criteria for Marketing Approval of Orphan Drugs - FDA View | PDF (340.7 KB)

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Article

Research Requirements and Criteria for Marketing Approval of Orphan Drugs -Industry View

Robert E. Keenan

Pages: 179-201

Published online: 28 Sep 2008

First Page PreviewforResearch Requirements and Criteria for Marketing Approval of Orphan Drugs -Industry View | References | PDF (721.5 KB)

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Article

Research Requirements and Criteria for Marketing Approval of Orphan Devices and Diagnostic Products-FDA View

Robert G. Britain

Pages: 207-214

Published online: 28 Sep 2008

First Page PreviewforResearch Requirements and Criteria for Marketing Approval of Orphan Devices and Diagnostic Products-FDA View | PDF (286.7 KB)

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Article

Research Requirements and Criteria for Marketing Approval of Orphan Devices and Diagnostic Products - Industry View

Floyd Benjamin

Pages: 215-223

Published online: 28 Sep 2008

First Page PreviewforResearch Requirements and Criteria for Marketing Approval of Orphan Devices and Diagnostic Products - Industry View | PDF (309.7 KB)

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Clinical Research and Regulatory Affairs (Vol.2, Iss.2, 1984)

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