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

2017 ◽  
Author(s):  
Kuehn
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Regulatory Policy ◽  
Patient Advocacy ◽  
The U.S

The role of the U.S. Food and Drug Administration in device evaluation and monitoring

2010 ◽  
Vol 72 (1) ◽  
pp. 5-10 ◽  
Author(s):  
David L. Diehl ◽  
William M. Tierney ◽  
Douglas G. Adler ◽  
Jason D. Conway ◽  
Francis A. Farraye ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Evaluation And Monitoring ◽  
The U.S

Role of the U.S. Food and Drug Administration in the Regulatory Management of Human Listeriosis in the United States

2008 ◽  
Vol 71 (6) ◽  
pp. 1277-1286 ◽  
Author(s):  
KARL C. KLONTZ ◽  
PATRICK V. McCARTHY ◽  
ATIN R. DATTA ◽  
JUDY O. LEE ◽  
DAVID W. K. ACHESON ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Demographic Trends ◽  
The Past ◽  
Compliance Programs ◽  
Regulatory Management ◽  
The U.S

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.

Thalidomide

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.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

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