scholarly journals PCN209 EVALUATING THE ROLE OF REAL-WORLD EVIDENCE FOR ONCOLOGY PRODUCT REGISTRATION IN THE UNITED STATES: A SYSTEMATIC REVIEW OF APPROVALS BY THE FOOD AND DRUG ADMINISTRATION FROM 2015-2019

2020 ◽  
Vol 23 ◽  
pp. S59
Author(s):  
M.S. Duh ◽  
R. Bhak ◽  
B. Arondekar ◽  
M. DerSarkissian ◽  
L. Huynh ◽  
...  
Keyword(s):  
United States ◽  
Systematic Review ◽  
Drug Administration ◽  
Real World ◽  
Food And Drug Administration ◽  
The United States ◽  
Real World Evidence

scholarly journals Use of Flavored E-Cigarettes and the Type of E-Cigarette Devices Used among Adults and Youth in the US—Results from Wave 3 of the Population Assessment of Tobacco and Health Study (2015–2016)

2019 ◽  
Vol 16 (16) ◽  
pp. 2991 ◽  
Author(s):  
Liane M. Schneller ◽  
Maansi Bansal-Travers ◽  
Maciej L. Goniewicz ◽  
Scott McIntosh ◽  
Deborah Ossip ◽  
...  
Keyword(s):  
United States ◽  
Smoking Cessation ◽  
Drug Administration ◽  
Smoking Status ◽  
Food And Drug Administration ◽  
The United States ◽  
Health Study ◽  
Population Assessment ◽  
The Us

The United States (U.S.) Food and Drug Administration has expressed concern about flavored e-cigarettes (e.g., JUUL brand) because they are appealing to youth who may be unaware that the product is addictive. The Population Assessment of Tobacco and Health Study Wave 3 provided data on flavor categories, type of e-cigarette product, and smoking status among past 30-day youth and adult e-cigarette users in the US. Most past 30-day youth and adult users reported using only one flavor category, with fruit (53% youth, 31% adult) being the most commonly reported category. Adults were far more likely to report using tobacco flavor alone, compared to any other individual flavor category or flavor category combinations (OR: 21.08, 95%CI: 5.92, 75.12). Whereas, youth were more likely to report using multiple flavor categories (OR: 2.03, 95%CI: 1.55, 2.65), with the most reported pairing being fruit and candy (36%). The variety of flavors on the market appeals to consumers of all ages. Although most past 30-day e-cigarette users reported only one flavor category, non-tobacco flavors were far more common among youth. Differences in flavor preferences among adult versus youth vapers may have implications for the role of flavors in both the initiation of youth vaping and adult vaping for smoking cessation.

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.

The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research

2015 ◽  
Vol 26 (9) ◽  
pp. 1324-1330 ◽  
Author(s):  
Ashley Adamovich ◽  
Susie Park ◽  
Gary P. Siskin ◽  
Meridith J. Englander ◽  
Kenneth D. Mandato ◽  
...  
Keyword(s):  
United States ◽  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
United States Food ◽  
States Food

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.

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