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Review article

First published 2023-1

Review of novel and supplemental approvals of the targeted cancer drugs by the Food and Drug Administration in 2021

Esin Aysel Kandemir

Journal of Oncology Pharmacy Practice

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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

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Research article

First published 1998-1

Report of the Council on Scientific Affairs * : Unlabeled Indications of Food and Drug Administration-Approved Drugs

Joseph W. Cranston, Michael A. Williams, Nancy H. Nielsen [...]

Therapeutic Innovation & Regulatory Science

Free access

Editorial

First published 2011-2

The United States Food and Drugs Administration Approves a Generic Enoxaparin

Frederick A. Ofosu

Clinical and Applied Thrombosis/Hemostasis

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Research article

First published 2026-2

Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration,2015 through 2023

Carla Barile Godoy, Reshma Ramachandran, Pradyumna Sapre [...]

Clinical Trials

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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

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Review article

First published 2022-3

US Food and Drug Administration Facilitated Pediatric Approval Programs: Application to Pediatric Neurological Disorders

Emily Da Cruz, Faraan Rahim, Monica Lemmon [...]

Journal of Child Neurology

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Other

First published 2001-1

The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

Janice M. Reichert, Jennifer Chee, Claire S. Kotzampaltiris

Therapeutic Innovation & Regulatory Science

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Research article

First published 2020-4

Estimated costs of pivotal trials for U.S. Food and Drug Administration–approved cancer drugs,2015–2017

Emily Han-Chung Hsiue, Thomas J Moore, G Caleb Alexander

Clinical Trials

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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

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