UNDERSTANDING CASE PROCESSING AND FDA SUBMISSION INTRODUCTION There is a major turnaround time for the hiring physicians and support staff. Physicians tend to terminate their position after three years‚ so that area is always understaffed. The support staff is frequently hiring new nurses‚ but it takes 1-2 months to fully train them. The support staff has a training center for all new hires. The new hires are trained in customer service and medical technology such as coding and triage.
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MERCK: OPEN FOR INNOVATION? Founded in 1891 as an American subsidiary of his German namesake‚ Merck was once considered the “undisputed king of the pharmaceutical industry with ground‐ breaking drugs”(The Chief Executive 2003). But for the last decade‚ Merck has gone through a period of stagnation; it began to lose exclusivity patents on blockbuster drugs and has witnessed Pfizer’s rise to top place in the industry. It seemed now that internal R&D that was once the company’s main asset would
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The first case study focuses in on the cognitive neuropsychological method in demonstrating the functionality of the brain’s ability to recall and identify sonic information‚ following the onset of Alzheimer’s. This design recognizes the distinction between the speech and language centres of the brain and its musical storage/abilities with dementia (Lola L. Cuddy and Jacalyn Duffin‚ 2005). It was hypothesized that the client’s ability to maintain positive recall of familiar tunes‚ and react to the
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10/6/2014 Case 3: Merck and River Blindness 1. Why was Merck hesitant about developing a human version of Ivermectin? Merck considered this opportunity as a high risk investment. The cost of developing the drug was estimated at $100 million. Even if it was successful to cure river blindness the victims were too poor to afford the drug. There was no way to distribute it in these rural areas were the victims were located. In addition‚ there was a possibility that people would misuse the drugs‚ which
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TO: Dr. Roy Vagelos‚ Chairman and CEO Merck Corporation. January‚ 1991. The decision to move forward with the program to donate the new drug Mectizan on a large scale to the affected population in the Third World needs to be systematically analyzed. There are two especially important angles from which this decision needs to be considered. The first concern that needs to be taken into account is that of the stockholders and investors in this company‚ whose interests you are ultimately charged with
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Margaret A. Hamburg‚ a FDA Commissioner who is credited with a master’s degree once said‚ “A safe global food supply can only be achieved through development of effective food safety management systems‚ which are essential to the well being of consumers‚ farmers‚ processors and manufacturers.” Food is a fundamental desideratum for survival‚ and the safety of food has been a controversial issue elevating up in America. The Food and Drug Administration (FDA) is the organization which governs food in
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including Bayer AG and Novartis are exploring a deal for Merck & Co Inc’s consumer healthcare business‚ as they seek to gain scale in a fragmented industry‚ according to several people familiar with the matter. Reckitt Benckiser Group PLC and Procter & Gamble Co are also among the parties that have held discussions with Merck about buying the unit‚ best known for Coppertone sunscreen and Claritin allergy medicine‚ the sources said this week. The Merck business‚ which also includes Dr. Scholl’s foot
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MGT 4083-Technology Strategy Case Analysis Merck & Co.: Evaluating a Drug Licensing Opportunity Introduction: Davanrik is a new drug developed by LAB Pharmaceuticals‚ which has the potential to treat depression and obesity. Davanrik was initially developed to treat depression by stimulating the receptor in the serotonin system that promotes anti-depression. However‚ it was discovered that Davanrik also blocks the receptor that causes hunger. LAB Pharmaceuticals obtained a patent for Davanrik
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I am passionate about having a rotation at the Food and Drug Administration (FDA) because I know that I would be exposed to various backgrounds of pharmaceuticals such as regulations‚ quality‚ standards of procedure‚ and policies. I believe the FDA’s Office of Pharmaceutical Sciences is the appropriate place to gain meaningful experience in the field of pharmaceutical regulation. I am particularly interested in working with the Office of New Drug Quality Assessment department in order to be familiar
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The FDA helps advance public health by speeding up product innovations. The public is informed with science-based in‚ Puerto Rico formation needed to use medicines‚ foods and devices to improve their health ( UDHHS‚ 2010). The FDA approval process not only makes sure that the product’s ingredients are safe but also that labels show all ingredients and do not make unverified claims. This has caused the FDA symbol to now become one that consumers trust(Gelinas‚ 2010). FDA’s Jurisdictions How far
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