U.s. Food And Drug Administration - 2538 Words

FDA’s position The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical devices in the context of granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, and post-marketing surveillance of the medical product. Pharmaceutical companies seek FDA approval for a new drug to be marketed which entails a long process. This process starts with submitting 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 the drug is safe and effective. On the other hand, there are many patients who could not be enrolled in clinical trials because they do not fit the inclusion criteria or because the study is for a different indication. However, in these cases the patient may be able to receive the product medication under certain criteria through expanded access. Since 1987, the FDA has established rules that have enabled patients to access drugs or biologics that are still in development for treatment purposes, but the access primarily is limited to patients with cancer and HIV infection. In 2009, the FDA promulgated a program called the â€Å"expanded Access† orâ€Å"compassionate use† program ( 21 CFR 312.1) with clear regulations and procedures which provide greater access to more patients whoseShow MoreRelatedU.s. Food And Drug Administration3715 Words   |  15 Pages U.S. Food and Drug Administration Proposed Rule to Extend Its Reigns Over E-Cigarettes Abstract The Food and Drug Administration (FDA) is a division of the Department of Health and Human Services (HHS) and received its name in 1930. Although the FDA’s roots can be traced back as far as 1862, its right as a regulatory agency came into effect under the 1906 Pure Food and Drugs Act. This legislation was created to eliminate misrepresentation of food and drugs in an effort to protect theRead MoreU.s Food And Drug Administration1753 Words   |  8 PagesOn December 1, 2014 the U.S Food and Drug Administration (FDA) established two new rules requiring menu labeling and vending machine labeling. What does this mean exactly, well when it comes to menu labeling any establishment that has 20 or more chains are now required to list the calorie information on their menus or menu boards. This not only includes sit-down restaurants but also drive-through windows and takeout foods. They also established another rule for vending machines which requires allRead MoreU.s. Food And Drug A dministration 20081687 Words   |  7 Pages U.S. Food and Drug Administration 2008, FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence U.S. Department of Health and Human Services, updated 2015, viewed 13 January 2016, . Williams, S 2016, Will 2016 Be Johnson Johnson s Best Year Yet? , The Motley Fool 1995 – 2016, Viewed 6 January 2016, . Wordsworth, M 2012, Johnson Johnson to phase out potentially harmfulRead MoreSupplements : Dietary Supplements, As Defined By The Fda ( U.s. Food And Drug Administration1344 Words   |  6 PagesIETARY SUPPLEMENTS Dietary supplements, as defined by the FDA (U.S. Food and Drug Administration), are products intended for ingestion which contain any ingredients which add further nutritional value to the diet. Dietary supplements fall under the food category and consist vitamins, minerals, herbs, amino acids, metabolites, extracts (U.S. Food and Drug and Administration (FDA), 2015). Supplements are taken by many people to assist in the building of muscle and to assist in recovery after workoutsRead MoreEnsuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration4116 Words   |  17 PagesEnsuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of foods, medical devices, and prescription and over-the-counter pharmaceutical drugs (medications). The FDA regulates and supervises medical devices and drugs throughout their development, manufacturingRead MoreEssay Bio-engineered Processed Food1667 Words   |  7 Pagesyears, food has been increasingly changing from natural food to bio-engineered processed food. Modern civilization has changed the type of food people intake. The market has found the way to conserve and present their food in a way which attracts customers to buy them. In today’s society, companies transport food to places which were difficult before to reach in other places. In consequence, companies began to utilize chemicals and preservatives in order to aid in the maintenance of the f ood duringRead MoreFrequency Of The Radio Frequency Technology1001 Words   |  5 Pagessignals back from the tag (U.S. Food and Drug Administration, 2014). The tags use the radio waves to communicate the identity to the nearby readers and this process can be active or passive (U.S. Food and Drug Administration, 2014). Passive RFID tags are powered by readers and do not require battery. The active RFID tags are powered by batteries. The RFID tags can store a range of information from one serial number to several pages of data (U.S. Food and Drug Administration, 2014). In the healthcareRead MoreVaccines Are Safe And Safe Today1231 Words   |  5 Pagesprovided to the public. Currently the U.S. Food and Drug Administration (FDA) is responsible for protecting the over all public health of the United States of America (U.S. Food and Drug Administration, 2015). The FDA protects the â€Å"public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation† (U.S. Food and Drug Administration, 2015). On the Medical aspect, theRead MoreSafety Of Food And Drugs Consumption1448 Words   |  6 PagesSafety in food and drugs consumption is a necessity to consumers. It is the FDA s responsibility to ensure food and drug safety for the public. That’s why the FDA is what happens when agency within the U.S. Department of Health and Human Services (HHS) responsible for ensuring the safety and effectiveness. As the Food and Drug Administration Progresses it had became a reliable source for Americans .President Theodore Roosevelt signed the Food, Drug, and Cosmetic Act in 1938 to provide the publicRead More History and Laws behind the Federal Food and Drug Act of 19061232 Words   |  5 PagesHistory and Laws behind the Federal Food and Drug Act of 1906 As one of the primary federal consumer-protection laws in existence today, The Federal Food and Drug Act of 1906 was a law that had two primary goals for food and drugs: (a) forbid harmful ingredients and additions and (b) demand labeling of ingredients to inform consumers. According to Janssen (1981), it was hoped that the enactment of this law would

Becoming a Marine Biologists - 1603 Words

The life of Marine animals lies in the hands of scientist who try to study and protect them. From the early years of human life, marine animals have taken a part in the lives of humans as a source of food and everyday uses, but as the years have progressed and humans got curious we have started to study marine animal life and there ecosystems. Marine life has aided us and also it has perished and is still experiencing loses. The marine biology world has helped marine animals and has hurt them, but the controversial issues might actually outweigh the good things marine biologists have done and learned. Marine biology is the study of the interactions of living things in and near the ocean ecosystem.(Cronin). A Greek philosopher named Aristotle was thought to be the first Marine Biologist. He documented and described many forms of marine life. During the Renaissance period, Europeans started to explore the world. At first the exploration was about conquering the new land and traveling to different lands, but over time the explorers became curious about the ocean and what was in it. Soon explorers began to take Naturalist on their explorations to make scientific discovers about the ocean and lands. By the mid eighteen hundreds explorations were being funded solemnly for scientific research. As an alternative to working on boats where specimens could only be collected and preserved (as dead) and long-term observations were impossible, many scientists began to conduct theirShow MoreRelatedIf You Are Interested in Marine Biology773 Words   |  3 Pages Marine Biology If you are interested in adventuring the depths of the ocean, being a marine biologist is the job for you. As a marine biologist you will need to have several years of schooling in order to have a successful career. Being a marine biologist can be an enjoyable and dangerous job, but the journey is worth the ride. Several people ask what is a marine biologist? There are various answers to this question. The best answer shall be that a marine biologist is someone who works in someRead MoreMarine Biology And Its Impact On Society1364 Words   |  6 PagesIntroduction Marine Biology is the scientific study of organisms in the ocean or other marine bodies of water. Marine Biologists are the examiners of this science. Marine Biologists play an important role in today’s society because 71% of the Earth is made up of water and only 5% of water on Earth has been discovered (â€Å"Ocean†). Without having these scientists in our communities today, the largest part of Earth would remain a mystery. The process of becoming a Marine Biologist is no easy task. ItRead MoreThe Ocean Has Been My Favorite Environment972 Words   |  4 PagesAustralia. It wasn t until I encountered a wild dolphin at Clearwater beach, Florida that I decided to be a marine biologist. The dolphin was so friendly and welcoming, swimming by me and my brother and allowing us to stroke his slimy skin. That experience will stick with me forever and is a huge part of why I want to pursue a career in marine biology. When I chose to be a marine biologist, my parents were very supportive. They would take us to the beach as much as possible for vacations, but alsoRead MoreA Successful Marine Biologist That Specializes The Natural Beauty Of The Oceans Ecosystem852 Words   |  4 Pagesgoing into outer space, not to say that it is impossible to reach such a far fetched goals. My main goals or â€Å"dream goals† that I am currently striving for are career based, and those goals are to one day become a successful Marine Biologist that specializes in cetaceans, marine mammals, while also trying my hardest to converse the natural beauty of the oceans ecosystem. Now this may not be the most finically sound job, or even easily achieved career, but for me it is not about the money or easy wayRead MoreA Student At Hampton University1190 Words   |  5 PagesHBCU’s. However, occasionally I find myself becoming frustrated when ask the question â€Å"why† in a way that questions the valid ity and or need for HBCU’s in 2016. As a student at Hampton University I did not fully realize the impact it would have on me, but looking back, it is clear to me that those experiences have shaped who I’ve grown into today, and strongly influence to my desire to pursue a career in environmental science education. My first class in Marine and Environmental Science department atRead MoreHelp Rescue And Rehabilitate The Animals909 Words   |  4 Pagesstudents would experience. They would gain one of a kind skills from these rescue and rehabilitation experiences. SeaWorld has a staff of animal care experts that can teach students their collective knowledge, because no one knows how to care for marine animals like SeaWorld. The Four actions of the Blue Ocean Strategy are raise, create, eliminate and reduce. By Following the Blue Ocean Strategy, we are eliminating the current need to gain practical experience after receiving your bachelors degreeRead MoreOverfishing Is A Problem For A Long Time1713 Words   |  7 PagesOver fishing has been a worldwide problem for a long time. Overfishing is not only a problem for Bluefin tuna (Thunnus thynnus) but with many other marine animals. The economic effect overfishing has on the cost of fishing and how it affects people is important. Overfishing has a huge economic effect on fishermen and the cost of fishing. Even though many people believe that overfishing is not that big of a problem, it seems to be an ongoing problem in the world. Overfishing is a major problem todayRead MoreI Want to Become a Marine Biologist536 Words   |  2 Pagesenlistment is up, I want to be a diver at an aquarium where I can feed the animals; Meanwhile, I would like to attend Rosen stiel School of Marine and Atmospheric Science at The University of Miami and earn a doctorate degree in Marine Biology to become a Marine Biologist. Ive always been fascinated with animals, especially aquatic life. Although, I wasnt dead-set on becoming one at first, over spring break I made my final decision. We went to an aquarium and I just loved every bit of it; the animal’s interactionsRead MoreOcean Science Class : A Marine Biologist963 Words   |  4 PagesFor the longest time I wanted to be a marine biologist, so I decided to take an Ocean Science class this semester and my professors name is Mr. Wayne T. Marko. I decided to interview him for that very reason. I wanted to know why he chose his field, but also why he likes to teach about the ocean. Mr. Marko has his Ph.D. in Geoscience and his M.S. in Geosciences from Texas Tech University. He also received his B.S. in Geological Sciences at the University of Southern California. Mr. Marko’s researchRead MoreW hat will the effects be if we dont stop plastic pollution in our oceans?991 Words   |  4 Pagesresearch scientist who specializes in plastics. It s still somewhere in the marine environment. (Doucette, para. 8) Said by The United Nations Environment Program, it is estimated that plastic debris kills more than 100,000 marine mammals and 1 million seabirds every year (Doucette, para. 9). Between 1970 and 2003, plastics became the fastest growing segment of the US municipal waste stream, increasing nine-fold, and marine litter is now 60–80% plastic, reaching 90–95% in some areas (Moore, para.

Arrow Electronics Case Study free essay sample

Arrow Electronics is the fastest growing distributors of electronic components in North America and the world’s largest overall at the time of this study. Arrow’s capital structure policy is heavy on dependence on debt financing, which is sharp in contrast to its main rival, Avnet. CEO Stephen Kauffman is struggling with the implementation of an accurate and reliable way to evaluate his employees. Kauffman implemented an EPR (Employee Performance Review) system that was currently not providing him with enough information that he needed to determine the level of performance given to him by his employees. Because of industry trends and compensation practices, the electronics distributors sales force is transitory. The industry has a high turnover in sales and usually when sales reps move to other companies they take their customers with them. For five years Arrow struggled with the accuracy and implementation of their EPR. Arrow saw problems ranging from inflated scores, ratings that reflected the self-serving bias of the managers who administered the appraisal, to lack of consistency. Kauffman decided to respond to these problems by providing training on how to scale, score and administer the appraisal. He made video notifiying managers exactly what he wanted and set goals to what percentage of employees should score in every single one of the categories. When Kauffman received the results from managers he became frustrated because the results were skewed. A problem existed with how the appraisals were given, but the real problem lied with the appraisal itself. The EPR that Arrow was asked to use was asking the managers to evaluate their employees compared to one another, rather than comparing them to expected standards using behavioral targets. The appraisal is worded in a way that each individual employee’s success is defined within the parameters of the success or failure of their coworkers. Because of this system, the appraisal was driving subjective feedback when Kauffman was looking for objective feedback. Building on this mishap, Kauffman’s system to evaluate his employees is used as a point in a field of data to determine an employee’s chance for promotion or termination. Kauffman states that he wants employees to understand that getting a low score is not punitive, but how would you respond if you received a low score? Kauffman needs to find a way to keep Arrow salespeople with Arrow. One way of doing this would be to have employees appraise their work satisfaction and have management develop and implement a system that increases the employee’s satisfaction. Arrow had a couple key company objectives. Arrow wanted to eliminate long turnaround to answer RFPs, improve sales process by automating quotes, reduce pricing and inventory errors, and expand information capture capabilities. Arrow Electronics was experiencing a competitive disadvantage because of long turnaround times on customer requests for product pricing and availability. Even though Arrow had a sophisticated quoting system, their customers submitted RFPs in multiple different formats such as Microsoft Word, Microsoft Access, Microsoft Excel, or CSV text file. Because of these different formats, this created turnaround and accuracy problems and required Arrow personnel to post data manually and prepare a response to the customer’s RFP. The costly delays that resulted from this turnaround resulted in lost sales. Scheihing had described the poor shipping performance as resulting from a late day surge in orders hitting the PDCs in large quantities that it was not possible to pick and ship them by the last carrier pick-up. When Scheihing was the operations manager in the Philadelphia branch, she recalled that late orders just meant a little overtime in the warehouse and an early start in the morning for their driver. With the closing of the local branch warehouses and the building of the four PDCs, the situation had changed. Scheihing needs to focus on what actions are needed to get the same day shipping performance back to 95%. One way of doing that would be to focus on pushing back the carrier pick up times, adding permanent full-time staff to handle the daily surges, and building a part-time staff to call in on short notice instead of only working more overtime. The Mainframe System that Arrow was using as a repository of all data and converted the orders received from the Sales Desktop to shipping instructions for the appropriate PDC was experiencing some problems. One of the abilities the Mainframe System had was the ability to track inventory at very detailed levels. There existed five possible on-hand positions for inventory that had been put on the shelf or picked for an order. Scheihing once remarked that Arrow was â€Å"controlled by the IT System. † Arrow was dependent on its systems and the information contained in them had to be accurate. Inaccurate inventory data has the potential to drastically affect Arrow’s performance. Arrow tracked their inventory accuracy and if it experienced dings between 2-5% then it needed â€Å"turning up. † Anything over 5% was a serious problem and would require a team from corporate to audit and suggest improvements. Sheihing believed that accurate data were central in such a way that failure to maintain data accurately resulted in managers being fired. Inaccurate inventory data could cause a trickle down affect that would negatively affect the way Arrow did business and portray them as someone who cannot be relied on as a successful business entity.

Locke VsHobbes Essay Research Paper Locke versus free essay sample

Locke Vs.Hobbes Essay, Research Paper Locke versus Hobbes Locke and Hobbes were both societal contract theoreticians, and both natural jurisprudence theoreticians, but at that place the resemblance ends. All other natural jurisprudence theoreticians assumed that adult male was by nature a societal animate being. Hobbes assumed otherwise, therefore his decisions are strikingly different from those of other natural jurisprudence theoreticians. What would life and human dealingss be like in the absence of authorities? Thomas Hobbes was the first to try to exemplify this status utilizing an rational device- a # 8220 ; thought experiment # 8221 ; , known as the # 8220 ; State of Nature # 8221 ; . For Hobbes, the province of nature was non an existent period in history, but instead a manner of apologizing how people would move in their most basic province. He believed that everything in the existence was merely atoms in gesture, and that geometry and math could be used to explicate human behaviour. Harmonizing to his theories, there were two types of gesture in the existence: Vital ( nonvoluntary gesture such as bosom rate ) , and Voluntary ( things that we choose to make ) . We will write a custom essay sample on Locke VsHobbes Essay Research Paper Locke versus or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page Voluntary gesture was so broken into two classs that Hobbes believed were mathematical equations-Desires and Aversions. Desires were things one was moved to or that were valued by the person, while antipathies were frights or things to be avoided by the person. Hobbes farther believed that an single # 8217 ; s appetite invariably kept him or her in gesture, and that in order to stay in gesture, everyone needs a certain grade of power. Therefore the chase of power is the natural province of worlds. Hobbes so says that nature ahs made work forces fundamentally equal. He besides says that people were invariably in a battle for power and above all else, they wanted to avoid a violent decease. In the province of nature, people were ever at war with one another, a war of all against all. Every individual had the right to make anything they pleased. Hobbes thought that this would travel on until people discovered that they could forestall their death by avoiding making things that would intentionally jeopardize their lives. Hobbes besides thought that an autocratic authorities would come to power in order to implement the societal contract by whatever agencies necessary. He called this Leviathan. Persons exchanged their rights in return for peace, security, and protection from one another. John Locke embraced many of the thoughts presented by Hobbes in his theories on the province of nature and the rise of authorities. They differed nevertheless, in that Locke believed that God was the premier factor in political relations. He believed that persons were born with certain rights given non by authorities or society, but by God. This he said, is what gives all people equality. Locke said in the province of nature work forces largely kept their promises and honored their duties, and, though insecure, it was largely peaceable, good, and pleasant. He says that worlds know what is right and incorrect, and are capable of cognizing what is lawful and improper good plenty to decide struggles. In peculiar, and most significantly, they are capable of stating the difference between what is theirs and what belongs to person else. Hobbes says that our cognition of nonsubjective, true replies on such inquiries is so lame, so little and imperfect as to be largely worthless in deciding practical statements. In a province of nature people can non cognize what is theirs and what is person else # 8217 ; s. Property exists entirely by the will of the province, so in a province of nature work forces are condemned to endless violent struggle. On the societal contract, Locke says we give up our right to ourselves. We retain the right to life and autonomy, and derive the protection of our belongings. Hobbes fundamentally says, if you shut up and make as you are told, you have the right non to be killed. On the Violation of the societal contract, Locke says that if a swayer seeks absolute power, if he acts both as justice and participant in differences, he puts himself in a province of war with his topics. Then he says we have the right to kill such a swayer. Hobbes says that we have no right to arise, because a male monarch can make no wrong.