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Literature DB >> 34694325

FDA Drug Approval and the Ethics of Desperation.

Emily A Largent¹, Andrew Peterson², Holly Fernandez Lynch¹.

Abstract

Entities: Chemical

Mesh：

Substances：

Year: 2021 PMID： 34694325 PMCID： PMC8649053 DOI： 10.1001/jamainternmed.2021.6045

Source DB: PubMed Journal: JAMA Intern Med ISSN： 2168-6106 Impact factor: 21.873

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5 in total

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

Authors: Holly Fernandez Lynch; Alison Bateman-House
Journal: J Law Med Ethics Date: 2020-06 Impact factor: 1.718

2. Conflicts of Interest for Patient-Advocacy Organizations.

Authors: Matthew S McCoy; Michael Carniol; Katherine Chockley; John W Urwin; Ezekiel J Emanuel; Harald Schmidt
Journal: N Engl J Med Date: 2017-03-02 Impact factor: 91.245

3. Promoting Patient Interests in Implementing the Federal Right to Try Act.

Authors: Holly Fernandez Lynch; Patricia J Zettler; Ameet Sarpatwari
Journal: JAMA Date: 2018-09-04 Impact factor: 56.272

4. Fulfilling the Mandate of the US Food and Drug Administration's Accelerated Approval Pathway: The Need for Reforms.

Authors: Bishal Gyawali; Joseph S Ross; Aaron S Kesselheim
Journal: JAMA Intern Med Date: 2021-10-01 Impact factor: 21.873

5. Approval of Aducanumab for Alzheimer Disease-The FDA's Perspective.

Authors: Billy Dunn; Peter Stein; Patrizia Cavazzoni
Journal: JAMA Intern Med Date: 2021-10-01 Impact factor: 21.873

5 in total

3 in total

FDA Drug Approval and the Ethics of Desperation.

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

2. Conflicts of Interest for Patient-Advocacy Organizations.

3. Promoting Patient Interests in Implementing the Federal Right to Try Act.

4. Fulfilling the Mandate of the US Food and Drug Administration's Accelerated Approval Pathway: The Need for Reforms.

5. Approval of Aducanumab for Alzheimer Disease-The FDA's Perspective.

1. The new therapy for Alzheimer's disease: from a hope for a few to a false hope?

2. The VA Goes Its Own Way on Aducanumab.

3. Aspiring to Reasonableness in Accelerated Approval: Anticipating and Avoiding the Next Aducanumab.