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Research article

First published 1996-7

Uses of Laboratory Data in anti Infective Drug Approval Processes *

Ralph D. Harkins

Therapeutic Innovation & Regulatory Science

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Review article

First published 2023-9

Generic drug application and approval process in Vietnam and Philippines

Sayali C Kankariya, Atish S Mundada

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Other

First published 1999-1

The Regulatory Approval Process of Animal Drugs

Stephen J. Gilbride, Michael J. McGowan

Therapeutic Innovation & Regulatory Science

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Other

First published 1987-10

The Drug Approval Process and the Information it Provides

Ann Myers, Steven R. Moore, Abraham G. Hartzema [...]

Annals of Pharmacotherapy

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Other

First published 1998-10

An Overview of the Regulatory Approval Process in Drug Development

Shein-Chung Chow, Annpey Pong

Therapeutic Innovation & Regulatory Science

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Other

First published 1997-10

Good Statistics Practice in the Drug Development and Regulatory Approval Process

Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

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Research article

First published 1992-7

Are Initiatives to Speed the New Drug Approval Process Working?

Kenneth I. Kaitin, Helen L. Walsh

Therapeutic Innovation & Regulatory Science

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Review article

First published 2023-6

Abbreviated new drug submission approval process: An overview

Sonali S Amrutkar, Sanjay B Patil, Atish S Mundada

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Other

First published 2001-2

Comparison of the Drug Approval Processes in the US,the EU and Canada

David Paul

Journal of Medical Marketing: Device,Diagnostic and Pharmaceutical Marketing

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Research article

First published 2018-9

Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review

Samuel A. Bonet, Farzan Sasangohar, Mark Lawley

Proceedings of the Human Factors and Ergonomics Society Annual Meeting

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