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1-10 of 594 results for Drug approval standards

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Select article: The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

Select article: A Pharmacogenomics Standard for FDA Drug Approval: Arbitrary and Capricious or Safe and Effective?

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Research article

First published 2004-12

A Pharmacogenomics Standard for FDA Drug Approval: Arbitrary and Capricious or Safe and Effective?

David J. Wu

Biotechnology Law Report

Select article: On the Amendments of China's Provisions for Drug Registration

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Research article

First published 2008-9

On the Amendments of China's Provisions for Drug Registration

Naiqing Zhao, Chen Yao, Jie Chen

Therapeutic Innovation & Regulatory Science

Select article: The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

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Other

First published 2003-10

The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

Kenneth I. Kaitin, Catherine Cairns

Therapeutic Innovation & Regulatory Science

Select article: Quality Standards for Antiretrovirals in Indian Pharmacopoeia

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Research article

First published 2012-9

Quality Standards for Antiretrovirals in Indian Pharmacopoeia

Kalaiselvan Vivekanandan, Hemant Sharma, Gyanendra Nath Singh

Therapeutic Innovation & Regulatory Science

Select article: Current System of Overseeing Drug Trials in Developing Countries by the FDA Is Dangerous

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Editorial

First published 2020-9

Current System of Overseeing Drug Trials in Developing Countries by the FDA Is Dangerous

C. Michael White

Annals of Pharmacotherapy

Select article: Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India

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Research article

First published 2014-5

Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India

Kalaiselvan Vivekanandan, Jai Prakash, Kalaivani Muthusamy [...]

Therapeutic Innovation & Regulatory Science

Select article: Report of a Workshop on Confirmatory Evidence to Support a Single Clinical Trial as a Basis for New Drug Approval *

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First published 2002-7

Report of a Workshop on Confirmatory Evidence to Support a Single Clinical Trial as a Basis for New Drug Approval *

Carl C. Peck, Jill Wechsler

Therapeutic Innovation & Regulatory Science

Select article: Internal Standards: Rationale for Use in a Drug Utilization Review Program

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Research article

First published 1981-10

Internal Standards: Rationale for Use in a Drug Utilization Review Program

Stephen L. Huber, Roland A. Patry

Annals of Pharmacotherapy

Select article: The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

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Other

First published 2000-1

The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

Kenneth I. Kaitin, Elaine M. Healy

Therapeutic Innovation & Regulatory Science

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