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.

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.

scholarly journals Prevalence of Cronobacter spp. and Salmonella in Milk Powder Manufacturing Facilities in the United States

2020 ◽  
Vol 83 (10) ◽  
pp. 1685-1692
Author(s):  
MELINDA M. HAYMAN ◽  
SHARON G. EDELSON-MAMMEL ◽  
PEGGY J. CARTER ◽  
YI CHEN ◽  
MONICA METZ ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Milk Powder ◽  
The United States ◽  
Sampling Location ◽  
Facility Locations ◽  
Buttermilk Powder ◽  
Powder Manufacturing ◽  
The U.S

ABSTRACT The U.S. Food and Drug Administration (FDA) conducted a sampling assignment in 2014 to ascertain the prevalence of Cronobacter spp. and Salmonella in the processing environment of facilities manufacturing milk powder. Cronobacter was detected in the environment of 38 (69%) of 55 facilities. The average prevalence of Cronobacter in 5,671 subsamples (i.e., swabs and sponges from different facility locations) was 4.4%. In the 38 facilities where Cronobacter was detected, the average prevalence of positive environmental subsamples was 6.25%. In 20 facilities where zone information of the sampling location was complete, Cronobacter was most frequently detected in zone 4, followed by zone 3, then zone 2, with zone 1 yielding the lowest percentage of positive samples. The prevalence of Cronobacter across the zones was statistically different (P < 0.05). There was no significant association between product type (i.e., lactose, whey products, buttermilk powder, and nonfat dried milk) and prevalence of Cronobacter in the facility. Salmonella was detected in the environment of three (5.5%) of the 55 facilities; all three facilities produced dried whey product. The overall prevalence of Salmonella in 5,714 subsamples was 0.16%. In facilities in which Salmonella was detected, the average prevalence was 2.5%. Salmonella was most frequently detected in zone 4, followed by zone 3. Salmonella was not detected in zone 1 or zone 2. The disparity between Salmonella and Cronobacter prevalence indicates that additional measures may be required to reduce or eliminate Cronobacter from the processing environment. HIGHLIGHTS

scholarly journals Regulation of E-Cigarettes in the United States and Its Role in a Youth Epidemic

Children ◽  
2019 ◽  
Vol 6 (3) ◽  
pp. 40 ◽  
Author(s):  
Mark Gottlieb
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Rapid Rise ◽  
Federal Regulation ◽  
Surgeon General ◽  
Cigarette Industry ◽  
If Current ◽  
The U.S

During the first decade of federal regulation of electronic nicotine delivery systems (ENDS), the e-cigarette industry has rapidly grown. Recently, the U.S. Surgeon General and Commissioner of the Food and Drug Administration each declared the rapid rise in rates of youth using these products to be an “epidemic.” While a foundational basis for regulating ENDS has been in effect since 2016, deferred enforcement has contributed to acute rise in use by youth. The Agency has undertaken several initiatives to address the problem and warned manufacturers that if current youth trends continue, it will be “game over.”

Recalls of Spices Due to Bacterial Contamination Monitored by the U.S. Food and Drug Administration: The Predominance of Salmonellae

2006 ◽  
Vol 69 (1) ◽  
pp. 233-237 ◽  
Author(s):  
VIBHA VIJ ◽  
ELIZABETH AILES ◽  
CECILIA WOLYNIAK ◽  
FREDERICK J. ANGULO ◽  
KARL C. KLONTZ
Keyword(s):  
United States ◽  
Drug Administration ◽  
Bacterial Contamination ◽  
Food And Drug Administration ◽  
The United States ◽  
Frequent Use ◽  
Control And Prevention ◽  
Human Illness ◽  
Using Data ◽  
The U.S

From 1980 to 2000, the annual per capita consumption of spices in the United States increased by 60% (from 1.0 to 1.6 kg per person per year). Although spices are known to harbor various molds, fungi, and bacteria, relatively few reports have documented this group of foods as the cause of human illness. In recent years, however, the U.S. Food and Drug Administration (FDA) has noted an increased number of recalls of dried spices due to bacterial contamination. Accordingly, we reviewed spice recalls that took place in the United States from fiscal years 1970 to 2003. During the study period, the FDA monitored 21 recalls involving 12 spice types contaminated with bacterial pathogens; in all but one instance, the recalled spices contained Salmonella. Paprika was the spice most often involved in the recalls. A wide variety of countries were the source of the recalled spices. Using data from the Centers for Disease Control and Prevention National Salmonella Surveillance System, we were unable to discern any increases in the reported incidence of laboratory-confirmed salmonellosis in states that received spices contaminated with selected rare Salmonella serotypes. A variety of effective methods exist to disinfect spices, procedures that have attained increased importance given the frequent use of spices in ready-to-eat foods and the potential for contaminated spices to cause widespread outbreaks.

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.

Growing Reliance on China for Medicines: A Role for Pharmacists in Assuring Quality

2020 ◽  
Vol 35 (3) ◽  
pp. 110-112
Author(s):  
Rosemary Gibson
Keyword(s):  
United States ◽  
Health Care ◽  
Health Care System ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Military Hospitals ◽  
Drug Shortages ◽  
High Standards ◽  
The U.S

The U.S. health care system is becoming increasingly dependent on China for medicines because it is the dominant world supplier of the ingredients needed to make thousands of medicines distributed to hospitals, pharmacies, and military hospitals. The United States is so dependent that if China stopped supplying ingredients, pharmacy shelves would be empty within months. The Food and Drug Administration is in the unenviable position of making tradeoffs between assuring high standards that Americans have come to expect and preventing drug shortages.

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

scholarly journals Estimating the number of symptomatic SARS-CoV-2 infections among vaccinated individuals in the United States-January-April, 2021

2021 ◽  
Author(s):  
Kiersten J Kugeler ◽  
John Williamson ◽  
Aaron Curns ◽  
Jessica M Healy ◽  
Leisha D Nolen ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Drug Administration ◽  
Vaccine Efficacy ◽  
Food And Drug Administration ◽  
The United States ◽  
Population Immunity ◽  
The U.S ◽  
Health Messaging

As of March 2021, three COVID-19 vaccines have been authorized by the U.S. Food and Drug Administration (FDA) for use in the United States. Each has substantial efficacy in preventing COVID-19. However, as efficacy from trials was <100% for all three vaccines, disease in vaccinated people is expected to occur. We created a spreadsheet-based tool to estimate the number of symptomatic vaccine breakthrough infections based on published vaccine efficacy (VE) data, percent of the population that has been fully vaccinated, and average number of COVID-19 cases reported per day. We estimate that approximately 51,000 symptomatic vaccine breakthrough infections (95% CI: ~48,000-55,000 cases) occurred in the United States during January-April 2021 among >77 million fully vaccinated people, reflecting <0.5% of COVID-19 cases that occurred during that time. With ongoing SARS-CoV-2 transmission and increasing numbers of people vaccinated in the United States, vaccine breakthrough infections will continue to accumulate before population immunity is sufficient to interrupt transmission. Understanding expectations regarding number of vaccine breakthrough infections enables accurate public health messaging to help ensure that the occurrence of such cases does not negatively affect vaccine perceptions, confidence, and uptake.

Univision, Telemundo, and the Rise of Spanish-Language Television in the United States

2020 ◽  
Author(s):  
Craig Allen
Keyword(s):  
United States ◽  
Mass Communication ◽  
The United States ◽  
Spanish Language ◽  
Spanish Speaking ◽  
History Of ◽  
English Speaking ◽  
American Society ◽  
The U.S

The first completely researched history of U.S. Spanish-language television traces the rise of two foremost, if widely unrecognized, modern American enterprises—the Spanish-language networks Univision and Telemundo. It is a standard scholarly history constructed from archives, original interviews, reportage, and other public materials. Occasioned by the public’s wakening to a “Latinization” of the U.S., the book demonstrates that the emergence of Spanish-language television as a force in mass communication is essential to understanding the increasing role of Latinos and Latino affairs in modern American society. It argues that a combination of foreign and domestic entrepreneurs and innovators who overcame large odds resolves a significant and timely question: In an English-speaking country, how could a Spanish-speaking institution have emerged? Through exploration of significant and colorful pioneers, continuing conflicts and setbacks, landmark strides, and ongoing controversies—and with revelations that include regulatory indecision, behind-the-scenes tug-of-war, and the internationalization of U.S. mass media—the rise of a Spanish-language institution in the English-speaking U.S. is explained. Nine chapters that begin with Spanish-language television’s inception in 1961 and end 2012 chronologically narrate the endeavor’s first 50 years. Events, passages, and themes are thoroughly referenced.

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