The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology

From 1986 to 2006, the incidence of listeriosis in the United States dropped from approximately seven to three cases per million population, a reduction that most likely reflects the joint efforts of industry, government, consumers, and academia. Herein, we describe the U.S. Food and Drug Administration (FDA) strategy over the past three decades to combat listeriosis. Specifically, we discuss early actions taken to address outbreaks during the 1980s, policy decisions regarding the presence of Listeria monocytogenes in FDA-regulated foods, FDA compliance programs with L. monocytogenes components, enforcement actions to remove L. monocytogenes–contaminated products from the market (i.e., recalls) or to prevent entry of such products into the market (i.e., import detentions and refusals), research milestones, outreach and education efforts, and selected special projects. Evolving demographic trends in the United States may pose a challenge to further reduction of the incidence of listeriosis.

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Fibrin Sealant and the U.S. Food and Drug Administration Review Process

SURGICAL ADHESIVES and SEALANTS ◽

10.1201/9780429332500-21 ◽

2020 ◽

pp. 163-172

Author(s):

W. A. Fricke

Keyword(s):

Drug Administration ◽

Fibrin Sealant ◽

Review Process ◽

Food And Drug Administration ◽

The U.S

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Role of patient advocacy stakeholders in science-based regulatory policy at the U.S. Food and Drug Administration (FDA)

10.17760/d20280899 ◽

2017 ◽

Author(s):

Kuehn

Keyword(s):

Drug Administration ◽

Food And Drug Administration ◽

Regulatory Policy ◽

Patient Advocacy ◽

The U.S

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Thalidomide

10.1093/oso/9780190697211.003.0003 ◽

2018 ◽

Author(s):

Joshua M. Sharfstein

Keyword(s):

United States ◽

Drug Administration ◽

Birth Defects ◽

Food And Drug Administration ◽

The United States ◽

Close Call ◽

The U.S

In 1962, the United States found itself transfixed by a crisis involving the medication thalidomide. Marketed widely in Europe for a variety of ailments, including nausea during pregnancy, thalidomide turned out to be a severe teratogen, causing thousands of severe birth defects in Germany alone. Yet as a result of diligence by the U.S. Food and Drug Administration (FDA), thalidomide was never approved for marketing in the United States.). When the close call came to light, Congress responded by granting the agency new authority, including the unprecedented power to require medications to be proven effective before sale. A key to turning tragedy into progress was the decision to highlight the central role of the FDA reviewer Dr. Frances Oldham Kelsey in protecting the nation.

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SARS-CoV-2 mRNA Vaccine Attitudes as Expressed in U.S. FDA Public Commentary: Need for a Public-Private Partnership in a Learning Immunization System

Frontiers in Public Health ◽

10.3389/fpubh.2021.695807 ◽

2021 ◽

Vol 9 ◽

Author(s):

Elissa R. Weitzman ◽

Amy C. Sherman ◽

Ofer Levy

Keyword(s):

Drug Administration ◽

Review Process ◽

Vaccine Development ◽

Food And Drug Administration ◽

Public Private Partnership ◽

System Model ◽

The Novel ◽

Private Partnership ◽

Academic Partnerships ◽

The U.S

As part of the U.S. Food and Drug Administration COVID-19 vaccine review process, public commentary was solicited offering an opportunity to reflect on vaccine attitudes that may impact the uptake of coronavirus vaccines. We identified themes in the commentary that highlighted the safety, efficacy, ethics, and trustworthiness and transparency regarding the novel mRNA COVID-19 vaccines. A “Learning Immunization System” model is proposed to optimize public, private, and academic partnerships relating to vaccine development and implementation.

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