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Retricted access

Research article

First published 2015-9

Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs

Frank J. Sasinowski, Erika B. Panico, James E. Valentine

Therapeutic Innovation & Regulatory Science

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Review article

First published 2016-12

Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals

Alex L. Woersching, Matthew E. Borrego, Dennis W. Raisch

Annals of Pharmacotherapy

Free access

Review article

First published 2021-06-18

Mini review: The FDA-approved prescription drugs that target the MAPK signaling pathway in women with breast cancer

Fatemeh Khojasteh Poor, Mona Keivan, Mohammad Ramazii [...]

Breast Disease

Open access

Research article

First published 2024-12

Repurposing FDA-approved drugs for COVID-19: targeting the main protease through multi-phase in silico approach

Ahmed M Metwaly, Eslam B Elkaeed, Aisha A Alsfouk [...]

Antiviral Therapy

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Research article

First published 1983-7

FDA Approval of Comparative Claims for Prescription Drugs-The Moxam Case

Daniel Marcus

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2019

FDA Reported Use of Patient Experience Data in 2018 Drug Approvals

Cameron M. Kieffer, Alexis Reisin Miller, Benjamin Chacko [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 1989-10

How the FDA Regulates Drug Promotion and Medical Education before Drug Approval

William W. Vodra

Therapeutic Innovation & Regulatory Science

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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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Research article

First published 2007-9

The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

James B. Graham, Ernst R. Berndt

Therapeutic Innovation & Regulatory Science

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Review article

First published 2023-1

Abrocitinib: A New FDA-Approved Drug for Moderate-to-Severe Atopic Dermatitis

Patrick O. Perche, Madison K. Cook, Steven R. Feldman

Annals of Pharmacotherapy

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