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1-10 of 317 results for accelerated approval

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

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Other

First published 2000-7

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

Daniel G. Mannix

Therapeutic Innovation & Regulatory Science

Select article: Faster Access to Drugs for Serious or Life-Threatening Illnesses through use of the Accelerated Approval Regulation in the United States

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Other

First published 1998-1

Faster Access to Drugs for Serious or Life-Threatening Illnesses through use of the Accelerated Approval Regulation in the United States

David M. Cocchetto, Douglas R. Jones

Therapeutic Innovation & Regulatory Science

Select article: Accelerated Approval of Aducanumab: Where Do We Stand Now?

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Editorial

First published 2022-6

Accelerated Approval of Aducanumab: Where Do We Stand Now?

Hedva Barenholtz Levy

Annals of Pharmacotherapy

Select article: RAC Approves Accelerated Review!

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Research article

First published 1994-06

RAC Approves Accelerated Review!

Human Gene Therapy

Select article: Accelerating regulatory approvals through the World Health Organization collaborative registration procedures

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Research article

First published 2016-10

Accelerating regulatory approvals through the World Health Organization collaborative registration procedures

Mercè Caturla Goñi

Pharmaceuticals Policy and Law

Select article: FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

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Research article

First published 2017-1

FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

Nehar Damle, Shilvi Shah, Praneeta Nagraj [...]

Therapeutic Innovation & Regulatory Science

Select article: Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

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Research article

First published 2019-3

Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

Makoto Tanaka, Naoki Matsumaru, Katsura Tsukamoto

Therapeutic Innovation & Regulatory Science

Select article: {BLR 1652}Multiple Sclerosis - Betaseron - Berlex Laboratories - Accelerated Approval

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News

First published 1994-03

{BLR 1652}Multiple Sclerosis - Betaseron - Berlex Laboratories - Accelerated Approval

Biotechnology Law Report

Select article: Accelerated Pathways Work—Now What? A Survey of Payers in the United States

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Research article

First published 2017-3

Accelerated Pathways Work—Now What? A Survey of Payers in the United States

Barry Farrimond, Jonathan J. Fleming, Mark Mathieu

Therapeutic Innovation & Regulatory Science

Select article: Facilitating Both Evidence and Access: Improving FDA's Accelerated Approval and Expanded Access Pathways

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Research article

First published 2020-6

Facilitating Both Evidence and Access: Improving FDA's Accelerated Approval and Expanded Access Pathways

Holly Fernandez Lynch, Alison Bateman-House

The Journal of Law,Medicine & Ethics

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