What Is The Food And Drug Administration Agency?

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

Food and drug administration is a department of U.S health and human services. It’s responsibility is to test the safety and efficacy of new drugs entering the market as well as to make sure that these medicines are quickly accessible to people. The Food, Drug, and Cosmetic Act has been passed in 1938 to ensure that foods other than meat, poultry and fish are clinically hygienic and safe to eat. This act also requires that the food should be labelled according to its content. (FDA.org) Drugs and tobacco are also regulated by FDA and in 1996, FDA strictly regulated the use of tobacco products like nicotine, cigarettes and smokeless tobacco, by children and adolescents because of the increase in diseases prevalence and tobacco addiction. Annually 40000 deaths are attributable to its use and most of them are of premature. Therefore the goal of FDA is to stop the tobacco addiction by minors and prevent the deaths and diseases due to nicotine addiction. (FDA vs Brown, n.d) This essay will cover the food and drug administration’s role in under and over regulating drugs and medicines and how it effects our economy, health care system and patients health and safety.

The Food and Drug Administration is the oldest consumer protection agency in United States (FDA 2). From recalls on food products to the monitoring of the safety of our medicine sources, the Food and Drug Administration (FDA) ensures that they are both safe and wholesome (FDA 1). The Food and Drug Administration also ensures that the cosmetics we use won’t harm consumers, and that radiation-emitting product such as microwaves are secure and effective (FDA 1).

The FDA’s origin did not begin as the federal consumer protection agency it is widely recognized for being today. Prior to the FDA transforming into the present-day agency, the FDA’s emergence can be traced back to the agricultural industry during the 1800’s (History, 2015). In fact, it was Congress that enacted the FDCA (Food, Drugs, & Cosmetics Act) of 1938 that created the modern-day FDA (Allen, 2013). Despite the FDA’s passing of the tobacco law, the ongoing issues concerning the under and over regulation of products, and the high number of drug recalls suggests that the

The Food and Drug Administration (FDA) approved naltrexone in 1994 to assist in the treatment of alcohol dependence (Mark et. al, 2003). According to multiple studies of various sizes the medication has been proven to be highly beneficial in assisting with alcohol withdrawal and relapse (Leavitt, 2002; Rohsenow, 2004; Williams, 2005). With the approval of the FDA and the backing of many studies, why is this wonder drug not being more widely used? The following will address how naltrexone works and how it compares to other medications used in the treatment of alcohol dependence. Also included is the reasoning behind the professional hesitance in prescribing naltrexone.

The FDA behaves in ways that enhance its reputation for protecting consumer safety and public health. As gauged by public opinion polls, the FDA remains one of the most popular agencies in government, regularly securing 70 percent or greater “approval” of its performance among sampled respondents.5 Buttressing this popularity are powerful symbolic lessons of history: The FDA is widely credited with saving thousands of American lives in its response to the sulfanilamide tragedy of 1937 and the thalidomide scandal of 1959–1961.6 Congress dramatically strengthened pharmaceutical regulations after each of these events. Thereby whether or not the agency deserves it, the FDA clearly possesses a reputation for protecting public health and consumer safety.

According to the regulations established by the FDA in 1992, “Under this policy, foods, such as fruits, vegetables, grains, and their byproducts, derived from plant varieties developed by the new methods of genetic modification are regulated within the existing framework of the act” (FDA). In other words, instead of creating new regulations that are specific to these completely unique food products, they are put within the umbrella of other “natural” products. As time passes it appears to be harder to establish strict regulations to manage genetically modified food. According to the Center for Food Safety the most current propose of the Food and Drug Administration establishes that agricultural biotech companies should notify the FDA within a period of 120 before the companies proceed to introduce the product to the market. Regrettably, there is not mention of any regulation that requires assessment for health and environmental safety. This leave the companies with the freedom decide the kind of test that they want to perform if they decide to do so. But most important if this proposal is successful approve it will mean that the companies will have the right to freely even control what they want to include on their labels, which it will most likely exclude the mentioning of genetically modified food.

Implementation of Good Clinical Practices under part 21 CFR 50 (protection of human subjects) which includes the document ICFs, under part 21 CFR 54 (Financial Disclosure), under part 21 CFR 56 (IRBs) and Under part 21 CFR 312 (Investigational New Drug Application) should be provided. [7] These documents will help us to ensure whether the study was performed with the willingness of subjects ' to participate and the subjects were aware of the risks and benefits to the exposure to the drug. And also the sponsor and investigator both had signed the financial disclosure forms.

The Food and Drug Administration is the oldest consumer protection agency in the United States (FDA) (Food and Drug Administration [FDA], 2009a). The agency grew from a single chemist in 1862 to a staff of 15,000 in 2014 2014, with employees consisting of chemists, pharmacologist, physicians, microbiologists, veterinarians, pharmacists (Swann, 2014). From recalls of food products to the monitoring of the safety of our medicine sources, the Food and Drug Administration ensures that they are both safe and wholesome (FDA, 2010b). The FDA also ensures that the cosmetics we use won’t harm consumers, and that radiation-emitting product such as microwaves are secure and effective (FDA, 2010b).

The Food and Drug Administration is one of the oldest protection agencies the United States has. They were formed to protect citizens from drugs, food, cosmetics, medical devices and other hazardous things. The FDA employ more than 2,000 scientists, 900 chemists and 300 microbiologists.

When it comes to clinical research, many people think of clinical trials, but that’s only merely a small portion of a process towards a medical development involving a process call bench to the bedside. Clinical research outline scientific investigation involving animal or human subjects helping translate basic research into new treatments that would be valuable to patients. Clinical trials can contain a variety of research under the departments of physiology and pathophysiology, health services, and mental health. Furthermore, the process of developing new treatments from the bench to the bedside come in three stages: basic research, transitional research, and clinical research.

Recent working experience for 21 months as a study coordinator at the cancer centre of Seoul National University Hospital has given me a greater passion for expanding my career of proficiency and growing my expertise in pharmaceutical research area. This experience also led to me learning much about not only the patients journey from diagnosis to chemo/radiotherapy but also whole process of clinical trials. I am familiar with a clinical trial protocol,

The United States Pharmacopoeia (USP) was established to set the standards for the manufacture, nomenclature, indications, and chemical characteristics of drugs and continues to do so today. In 1938, the Pure Food and Drug Act created the FDA, to ensure the, “safety, efficacy, and appropriate labeling and advertising of pharmaceutical products before approving them for sale” (Blum, 2002). Prescription drugs are developed and both pre-clinical and

The Food and Drug Administration is the most crucial organization that is affiliated with reducing adverse drug events. Its mission as a department is to “[protect] the public health by assuring the safety, efficacy and security of human and veterinary drugs.” Under the United States Department of Health & Human Services, the FDA is also responsible to provide scientific studies and statistics to help citizens improve and maintain their health. This is achieved by carrying out surveys and influencing residency programs to be aware of these problems.The FDA also has close knit relationships with pharmaceutical companies to ensure safety and quality of drugs (David 2010). Therefore, this department has a broad regulatory authority that oversees

Addictive and enticing, sweetness does not just come from sugar (BE#2). Artificial sweeteners add to the sugary taste of many foods and go by many names – saccharin, aspartame, and sucralose ¬– but they are all formulated by chemical engineers. The Food and Drug Administration (FDA) describes artificial sweeteners as “probably safe,” and this statement has proven to be quite true (Nestle). For several years, aspartame and saccharin have been linked to weight gain and cancer in consumers and lab animals (Nestle). Because artificial sweeteners are used in many food products (most commonly diet sodas), people consume them quite often (BE#3). Also, humans tend to believe that if there are no calories and if there is no sugar, they should drink diet soda instead of regular soda. This trend leads to even greater intakes of sweet chemicals such as aspartame in people’s diets. Aspartame is a controversial and common ingredient in the American diet. “Aspartame, when reacted in the body, changes to methanol and then formic acid (a toxic substance)” (Nestle). According to the American Cancer Association, because aspartame contains phenylalanine, those who consume the substance regularly run the risk of having a build up of phenylalanine, which could constrict the flow of nutrients to the brain. Many people, though, do not show signs or symptoms of health complications consistent with aspartame (Amer. Cancer Assn.). Aspartame has the potential to be quite harmful, but because nobody has