Food And Drug Administration Case Study

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 (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. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

The case of ‘Tanner Pharmaceuticals and the Price of a New Drug’ discusses the pricing increase of a new life-saving drug titled ‘Zorstat’ aimed to fight Nulux virus developed and introduced by Tanner Pharmaceuticals which is the only producer of the drug. The price of the drug in the U.S. has been increased by 550% within 5 years. Now, Tanner Pharmaceuticals has started receiving flak in the press and by the politicians.

The U.S. Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services that is responsible for assuring the safety, efficiency, and quality of drugs and vaccines. In America a drug must first be evaluated by the Center for Drug Evaluation and Research (CDER), which is a division of the FDA, before it gets approved for sale. This means that the department must make sure that the medicine been evaluated works properly and that its health benefits are greater than its identified risks. A company or a sponsor that is introducing the new drug initially performs a laboratory and animal tests to determine the safety and the effectiveness of the drug in humans. Once this step is successfully completed, several tests are implemented in people to confirm that the drug is safe when used to treat a disease and whether it provides a real health benefit. Finally, results of the tests that prove the safety and the effectiveness of the treatment are sent to the CDER. After a group of experts at CDER reviews the submitted evidence and ensures that the medicine's health benefits surpass its known risks, the drug can then be sold around the US (Development & Approval Process (Drugs), 2014).

Today there are more cosmetic 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 much has been done to change neither the ingredients nor information the general public knows of this problem. The FDA does little to nothing to regulate known toxic ingredients, but alternative ingredients have been

Everyone wants the miracle drugs to be approved faster and get to market quicker; however the safety of the consumer needs to be a priority. Oversight of the manufacturing and approval process is a necessity to ensure the safety of the

Direct Regulation. The paper suggests that the FDA should rely on a more flexible and adaptive rather than stringent strategy. However, it ignores two serious implications of such an approach. First, this approach would most likely place medical professionals in a more insecure position regarding the devices that they use to evaluate the patients’ medical condition. As claimed in the paper, medical professionals “possess the knowledge and training to evaluate and make choices between medical products.” With a flexible and adaptive approach, it appears that the safety and effectiveness of a variety of devices would remain unproven. Should the market be flooded with such low-quality devices? My answer, by and large, is “no.” In this situation,

So much comes into play when diagnosing and prescribing. With more knowledge comes more experience in Pharmacology. I hope to take all this knowledge and make a natural language I can understand and communicate. But I take the time to share things I have researched and what I have grasped. Understanding the indicators are a crucial to seeing how to diagnose an individual. I have seen how symptoms can indicate a disease or condition. I have seen first hand how a relative has used multiple conditions to pinpoint what condition they had. It took time but after paying attention to every small condition there was a possible common denominator.

“Is it FDA approved?” Today, we hear more of this question and would check for the “FDA approved” stamp on the product before purchasing it. This behavior signifies the accountability of the agency, on how it has impacted the choices made by the people. This may not always be the case, however, for there are people who do not find the label necessary or would be applicable to their lifestyle. Nevertheless, this agency has made its mark in history to watch over the products being purchased by the consumers. Food and Drug Administration (FDA) is an agency under the Department of Health and Human Services. Its main responsibility is to protect the public health by assuring safety, efficacy and security. FDA assures safety by allowing

Some of the programs include are PDUFA program that provides certain trainings to Scientists and physicians in using technologies to speed up the process of the trials. This program has cut the review time by 60% and also facilitate FDA in communicating with drug companies, while the approval is in process, to effectively identify drug developmental procedures. The FDA uses Fast Track, accelerated approval, priority review and expanded access programs to speed up the process of drugs testing, approval and availability. FDA is not alone in all these innovative findings. Many of the pharmaceutical companies are working hand on hand with FDA to provide patients access to life saving drugs. approaches to ensure foods safety. Many staff members including the scientists are involved with FDA in regulating the approval of safe and effective drugs. Several awards have been given to FDA scientists who have worked hard and performed well in their field of research. These awards include Excellence in Analytical Science Award , Excellence in Laboratory Science Award ,Excellence in Review Science Award,Lifetime Achievement Award, Outstanding Junior Investigator Award, Outstanding

1. Identify at least three times during this video that the error could have been prevented.

The biopharmaceutical industry has historically been dominated by large companies. The threat of new entrants is low, but not impossible. The main path for entry into this market is through development of novel new drugs. New entrants are limited to this method of entry due to patent thickets surrounding incumbent drugs. The largest barrier to entry for companies attempting to enter the biopharmaceutical industry is high research and development costs. Not only must new firms develop and test new therapies, but they must also obtain approval from regulators in order to bring their products to market. Approval of a new drug requires highly capital intensive clinical test in addition to navigating a heavily bureaucratic approval process. The process is time consuming and

As it is mentioned earlier, medication administration includes various steps and an interdisciplinary team. Undoubtedly, nurses play a vital role in the medication administration process. Since patient safety is the priority to all health care professionals, it is important for the nurses to effectively communicate and collaborate with an interdisciplinary team if he or she is unsure about any medication prescription to prevent any adverse events. In addition, patient education is another component of safe administration. A patient must be educated on medications they are taking, the reason for taking them, the dosage, a route, potential side effects, and interactions. Nurses should perform “six rights” of the medication each time. Before administering

The United States have to go through a broad review in order to get the approval process by the Unites States Food and Drug Administration before any drugs can be prescribed to any of it patients. By the end of the year 2016, according to the 3.2 billion drugs were ordered from many physician practice for there patients (CDC, 2016). Many of these good and some are harmful drugs have bombarded numerous of pill bottles. Currently, the drugs supposed to go through a process of development, and next approval before being introduce/marketing to patients as well as consumers. However, having a clear outlook at the procedures that should be required to market drugs from the beginning to the end. Also, topics about the testing in

The recommended dose is IV/IM 1-2 mg every 8-12 hours (max: 6 g/day) (Adams & Urban, 2016). The drug is supplied for use as an IV medication. The patient’s 200 mg PO BID dose is not an appropriate route of administration.