The Food And Drug Administration Essay - 848 Words

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical device in context to granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, post-marketing surveillance of the medical product, etc. The Pharmaceutical companies seek for FDA approval for a new drug to be marketed through a long process. This process starts with applying an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that drug is safe effective. On the other hand, there are many patients unable to enroll in a trial because of exclusion criteria or because the study is for a different indication.However, when patient unable to enroll in a clinical, patients may be able to receive the product, when appropriate, through the Expanded access. ïÆ'ËœLegal arguments and implications:- (i) On 2009, the FDA promulgated a program called the â€Å"Expanded access† orâ€Å"Compassionate use† ( 21 CFR 312.1) which allows the patients to have an access to a Investigational Medicinal product which is subjected to Investigational New Drug (IND) application (according to an IND 21 CFR 312.8). The FDA in 2009 revised the regulation of â€Å"Expanded access† because there was no clear regulation related to different types of patients, and the access toShow MoreRelatedThe Food And Drug Administration1204 Words   |  5 PagesThe Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Dr ug advertisements make false and misleading claims, products areRead MoreThe Food And Drug Administration1017 Words   |  5 Pagescosmetic products on the market all over the world than ever before. There has also been an emphasis on beauty and how one presents themselves to others. The combination of these factors lead to an increase in demand for cosmetics. The Food and Drug Administration (FDA) has little to no control over the regulation over the safety of the ingredients included in personal care products on the market. Problems arise because there are known and identified toxic chemicals in many cosmetics, but not muchRead MoreThe Food And Drug Administration898 Words   |  4 Pagespolicy, 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 â€Å"natural† products. As time passes it appears to be harder to establish strict regulations to manage genetically modified food. AccordingRead MoreThe Food And Drug Administration1740 Words   |  7 Pagesto decline and present a risk to future food security. As a world, we are facing an adaptation deficit leaving us very vulnerable and thus, we must seek to find alternative resources to adapt and mitigate the risk to agriculture. One solution might be attributed to genetically modified foods, which are found in 80% of processed foods today, much to the unawareness of public consumers. In America, the Food and Drug Administration has the authority over food labeling and it has concluded that thereRead MoreThe Food And Drug Administration1903 Words   |  8 Pages2016. On December 1, 2014, the US Food and Drug Administration released a Final Rule clarifying the requirements, which include easy-to-see calorie counts for all â€Å"standard menu items,† as well as the inclusion of statements communicating the average daily intake of 2,000 calories and informing consumers that more detailed nutritional information can be obtained by request (Goldman, 2015). The goal of this rule is â€Å"to make nutrition information for certain foods available to consumers in a directRead MoreThe Food And Drug Administration2463 Words   |  10 PagesConsumers thus should be concerned what they put in their bodies. The Food and Drug Administration is regulating food, but people are sicker now than they ever have been. Not only them, but the big pharmaceutical companies also play a role in this giving drugs to people to help their problems but end up with a host of other problems from their fix. With this project I hope to show how incompetent the Food and Drug Administration is by unveiling what synthetic vitamins really are, the chemicals usedRead MoreThe Food And Drug Administration843 Words   |  4 PagesThe 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 worksRead MoreThe Food And Drug Administration1142 Words   |  5 PagesAndy Nunez English 1101 Amy Sandefur 9 September 2014 Dear Michael Taylor, As senior advisor of the Food and Drug Administration (FDA), I understand that you must have thousand of proposals being addressed to you everyday. I also understand that the FDA is responsible for tests that use dogs, primates and other species as test subjects to meet legal safety requirements. (Navs.org) At the same time, I, and millions of other people believe that the laws on animal experimentation need to be reviewedRead MoreThe Food And Drug Administration1430 Words   |  6 Pagesto the sugary taste of many foods and go by many names – saccharin, aspartame, and sucralose  ¬Ã¢â‚¬â€œ but they are all formulated by chemical engineers. The Food and Drug Administration (FDA) describes artificial sweeteners as â€Å"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 pro ducts (most commonly dietRead MoreThe Food And Drug Administration1298 Words   |  6 PagesIn 2000, the US Food and Drug Administration issued a health claim which states that consuming foods containing plant sterol and stanol esters along with other low cholesterol and saturated fat foods can reduce the risk of coronary heart disease (Jones, Vanstone, Raeini-Sarjaz, St-Onge, 2003). Today, many functional foods in the form of margarines, spread, yogurt, and others, have been enriched with phytosterols and advocated as being able to reduce the risk of coronary heart disease. Phytosterols