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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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Research article

First published 2018-9

Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market

Peter A. Patriarca, R. Michael Van Auken, Scott A. Kebschull

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2006-6

Food and drug administration (FDA) approval status of biologicals used in rheumatology

V Arya

Indian Journal of Rheumatology

Retricted access

Research article

First published 2018-8

The inadequacy of the reductionist approach in discovering new therapeutic agents against complex diseases

Manuel X Duval

Experimental Biology and Medicine

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Other

First published 1987-10

The Drug Approval Process and the Information it Provides

Ann Myers, Steven R. Moore, Abraham G. Hartzema [...]

Annals of Pharmacotherapy

Retricted access

Research article

First published 2013-4

Unapproved Drugs—The Drug Information Pharmacists’ Perspective

Mary Giouroukakis, Megan Dryer

Journal of Pharmacy Practice

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Research article

First published 2016-11

FDA safety actions for antidiabetic drugs marketed in the US,1980–2015

Christina S. Kwon, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio

International Journal of Risk & Safety in Medicine

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Research article

First published 2019-12

The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation

Alexander Khoruts, Diane E. Hoffmann, Francis B. Palumbo

The Journal of Law,Medicine & Ethics

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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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Research article

First published 2018-8

Sex,drugs,and rhetoric: The case of flibanserin for ‘female sexual dysfunction’

Judy Z Segal

Social Studies of Science

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