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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 1985-4

Switching-the Triple Threat from Tylenol® to Ibuprofen

Peter D. Bewley

Therapeutic Innovation & Regulatory Science

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Other

First published 1985-4

RX-TO-OTC Switch—The Process and Procedures

Ann H. Wion

Therapeutic Innovation & Regulatory Science

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Research article

First published 1988-1

Current Status of the NDA Tracking System at the FDA

Russell J. Abbott

Therapeutic Innovation & Regulatory Science

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Research article

First published 2008-04

Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

Biotechnology Law Report

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First published 2000-7

Irinotecan—a Case Study for the Transition from Accelerated Approval to Traditional Approval

Daniel G. Mannix

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2005-5

Application of Emerging Technologies in Toxicology and Safety Assessment: Regulatory Perspectives

John K. Leighton

International Journal of Toxicology