• Proceedings of the Korean Society of Toxicology Conference
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• 2006.11a
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• pp.75-79
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• 2006

The United States Food and Drug Administration is responsible for ensuring US residents receive safe and effective medicines. Since blood levels of drugs are correlated with pharmacological effect, FDA closely regulates how those blood levels are measured. The FDA has established requirements for bioanalytical analyses such as minimum method validation, SOP, and reporting criteria. The FDA also has standards for computer validation which must be followed to ensure the data are reliable. Data presented to the Agency are scrutinized to ensure they are accurate and a true reflection of the raw data generated in a study. To verify the quality of data, FDA has developed an inspection program. The specific requirements of the FDA related to bioanalysis will be discussed.

• Genomics & Informatics
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• v.12 no.4
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• pp.151-155
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• 2014

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

• Food Science and Industry
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• v.49 no.3
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• pp.55-61
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• 2016

Even though the food safety system in the United States is one of the best in the world, many millions of people become sick and thousands die from foodborne illnesses caused by any of a number of microbial pathogens and other contaminants. Large recalls of United States Department of Agriculture (USDA) and the Food Drug and Administration (US FDA)-regulated food products due to findings of E. coli O157:H7, Listeria, Salmonella, and other problems occur each year. As the US FDA Food Safety Modernization Act (FSMA) passed in 2011, FSMA will require food processing, manufacturing, shipping, and other regulated entities to conduct an analysis of the most likely safety hazards and to design and implement risk-based controls to reduce or eliminate these hazards. FSMA also mandates increased scrutiny of food imports, which account for a growing share of U.S. food consumption; food import shipments will have to be accompanied by documentation showing that they can meet safety standards that are at least equivalent to those in the U.S. On September 17, 2015, the US FDA published final rules for Preventive Controls for Human and Animal Food and, continuing into 2016, the US FDA intends to finalize the remaining five rules it has proposed to implement FSMA. Among these rules, this article will review and discuss Preventive Controls for Human Food Rule and its components, and suggest how to comply with these FSMA rules as foreign human food and ingredients suppliers to the US.

• The Korean Journal of Applied Statistics
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• v.18 no.1
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• pp.159-171
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• 2005

The US Food and Drug Administration(FDA) recommends that population bioequivalence and individual bioequivalence would be assessed to address the prescribability and switchability between a brand-name drug and its new formulation or generic copy in its 2001 guidance document. The test for population bioequivalence in the latest FDA guidance is recommended in 2 x 4 crossover design, but it turns out to be very conservative. Recently Lee, Shao & Chow(2002), Chow, Shao & Wang(2003) and McNally, Iyer & Mathew(2002) proposed new statistical methods for assessing population bioequivalence between drugs to correct the biasness of current FDA method. Since 2 x 2 crossover experiment is most welcomed design in bioequivalence testing, we adopt their methods to 2 x 2 crossover designs and compare their methodologies with FDA one through the simulation study.

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.91-92
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• 2003

Virtually every state in US has adopted laws and regulations that mandate the generic substitution of brand-named prescription drugs in order to reduce sky-rocketing drug costs. In the late 1970s, many state governments began to recognize the need of generic substitution and requested Food and Drug Administration (FDA) to consult with this issue. FDA did consult which drugs were interchangeable each other based upon the available scientific and experimental evidences given to the agency along with New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). (omitted)

• The Microorganisms and Industry
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• v.27 no.1
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• pp.18-22
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• 2001

• The Korean Journal of Medicine
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• v.93 no.6
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• pp.501-508
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• 2018

Obesity is a chronic disorder that is a significant risk factor for diabetes, cardiovascular diseases, malignancy, and other chronic diseases. Lifestyle modifications form the basis of most treatments for obesity, but it has become clear that such modifications alone are not enough for many obese patients. When a behavioral approach is insufficient, pharmacological treatment may be recommended. In recent years, the US Food and Drug Administration (FDA) has withdrawn several therapeutic options for obesity due to their side effects, but has approved four novel anti-obesity agents. Until recently, orlistat was the only drug approved for the management of long-term obesity, but the US FDA approved the novel anti-obesity drugs lorcaserin and phentermine/topiramate in 2012, and naltrexone/bupropion and liraglutide in 2014. The present review discusses the different pharmacotherapeutic options for the treatment of obesity.

• Journal of the Korea Institute of Military Science and Technology
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• v.19 no.1
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• pp.119-126
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• 2016

The US Army used MARK-1 composed of atropine autoinjector and 2-PAM autoinjector as a medical countermeasure against nerve agent poisoning. Recently, it has been being replaced by the ATNAA(Antidote Treatment Nerve Agent AutoInjector) for improvement the convenience in use and rapid detoxification effect. ATNAA(FDA approval, NDA 21-175, 2002. 1. 17) is a multi-chambered autoinjector that sequentially delivers atropine and 2-PAM through a single needle to allow Warfighters to survive against lethal exposure to nerve agents. In this paper, our group investigated the case of FDA approval of ATNAA in a point of the various data required by FDA guideline, thereby making it easy to meet the KFDA guideline for the approval of the prototype our group has been developed. The purpose of this study is to provide a reference for efficient research activities to minimize time and cost. Additionally, the purpose of this study is to provide a reference for the planning for the development of similar drug.

• Journal of Community Nutrition
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• v.5 no.4
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• pp.239-245
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• 2003

Millions people in the US suffer from foodborne illnesses each year. In the US, multiple government agencies work separately or together to ensure the nation's food safety for different audiences. FDA plays a key role in ensuring food safety in foodservice operations by providing the Food Code. School foodservice operations must follow the FDA guidelines on food safety and make sure that foods produced in school foodservice are safe. Despite the continuous efforts, school foodservice operations were responsible for numerous foodborne outbreaks. Currently, school foodservice operations serve younger children (<5 years) and children with medical conditions which make the food safety extremely important. There are many programs that foodservice operators can use to train and educate their employees. ServSafe$\^$ⓡ/tate or local food safety education programs, Serving It Safe, and HACCP workshop are common programs that can be used to train their staff. HACCP is a preventative program that can prevent foodborne illnesses before they occur. Although there are many benefits of utilizing HACCP and training programs, a majority school foodservice directors and managers still did not implement HACCP nor perceived their food safety training is adequate. Most reasons why not implementing HACCP program are lack of trained personnel, time, and financial resources in the school foodservice systems. The gap between what people know and what people do is another challenge identified as an obstacle food safety programs. Despite safe food sources in the US, continuous training is necessary to remove human errors and ensure food safety in the school foodservice systems. Future research is recommended to reduce gap between food safety knowledge and behavior. Foodservice operators and researchers may apply the systems developed in the US to their food systems.

• Journal of the Institute of Electronics Engineers of Korea SC
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• v.48 no.5
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• pp.74-80
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• 2011

Medical implant devices are one of the targets of the US's Food & Drug Administration (FDA) for tracking in case of a serious adverse event since they are directly connected to the lives of patients. The US law stipulates that the public health agency shall order implantable device makers to track their product down to the patient level if a serious adverse event has occurred or defects have been discovered; in reality, however, the agency can pass on the responsibility for tracking or recalling faulty devices to the manufacturers or use mass media. This article proposes an efficient tracking and recall management system and examines four main virtual scenarios based on such. This research seeks to suggest a system that enables FDA to perform accurate and prompt tracking and recall management for patients' enhanced safety.