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Articles (63)

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1-10 of 63 results for Expedited Drug Approvals

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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: The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

Select article: Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

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Research article

First published 2019-11

Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

G. Caleb Alexander, Ken Ogasawara, Dana Wiegand [...]

Therapeutic Innovation & Regulatory Science

Select article: Expedited approval programs at the Food and Drug Administration

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Editorial

First published 2018-6

Expedited approval programs at the Food and Drug Administration

Colin B Begg, Susan S Ellenberg

Clinical Trials

Select article: The Impact of Breakthrough Therapy Designation on Drug Safety

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Research article

First published 2025

The Impact of Breakthrough Therapy Designation on Drug Safety

Hanu Tyagi, Rachna Shah

Production and Operations Management

Select article: FDA's Expedited Approval Mechanisms for New Drug Products

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Research article

First published 2015-02

FDA's Expedited Approval Mechanisms for New Drug Products

Erin E. Kepplinger

Biotechnology Law Report

Select article: Can the New Drug Approval Process Be Expedited by Amending the IND Regulations?

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Research article

First published 1981-7

Can the New Drug Approval Process Be Expedited by Amending the IND Regulations?

Dorothy S. Dobbs

Therapeutic Innovation & Regulatory Science

Select article: Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

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Other

First published 2001-1

Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

Christopher-Paul Milne, Elaine Bergman

Therapeutic Innovation & Regulatory Science

Select article: Development of Drug-Approval Regulations for Medical Countermeasures Against CBRN Agents in Japan

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Research article

First published 2015-04

Development of Drug-Approval Regulations for Medical Countermeasures Against CBRN Agents in Japan

Rumiko Shimazawa, Masayuki Ikeda

Health Security

Select article: Ethical challenges and opportunities in the development and approval of novel therapeutics for rare diseases

Open access

Review article

First published 2023

Ethical challenges and opportunities in the development and approval of novel therapeutics for rare diseases

Djurdja Djordjevic, Andrew McFadyen, James A Anderson

The Journal of Medicine Access

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