Fda Drug Review Essay

This report is Part 1 of assignment for Marketing MBA 565-MBOL1 to Dr. Stephen Baglione

Although the FDA prolongs this process for safety concerns, I personally feel that they should be able to expedite their approval. The reason for expedition is because more and more people are being diagnosed with multiple health issues. Some people are more desperate then others and feel they can benefit from the drug as it is. Therefore, if a person wants to take a drug that has not been approved yet, then they should be able to

Pharmacy is a prolific field of study that is taking a prime position in the world of academia. It is quite demanding and needs completeness and vigilance. Thus, by going through pre-pharmacy, it will help me reshape my educational and career aspirations by bringing into reality what pharmacy entails through prerequisite coursework. I will also be able to come to terms with what the profession has at the end of the tunnel and asses with it marches my career goals. The profession is loaded with numerous employment and personal advancement opportunities, and I am motivated to study pre-pharmacy since it will spark of my innovativeness and optimistic that my future days would be worth the trouble.

The aim of this assignment is to demonstrate the use of safe and effective prescribing in practice. I will achieve this by presenting and analysing a prescribing scenario which I have encountered in my current area of practice within a District Nursing Team. During the case study the patient I have chosen will be referred to as Jean. This is to maintain her anonymity in line with the Nursing and Midwifery Council (2008) guidelines of confidentiality.

In our experience with Pharmasim we learned that Marketing decision making must be very sensitive and responsive to everything going on in the industry which is very complex. Consumer responses to marketing tactics can be volatile and unpredictable and no idea is guaranteed to work well. Marketing is a matter of meticulous research, assumptions, planning, and volatility at times. Overall we took away two major points: 1) that it is important to consider the product lifecycle in evaluating how to promote businesses and, 2) that the “Sweet Spot” as a competitive advantage should be the greatest point of consideration when evaluating how to best gain leverage to beat the competition in the minds of

Graham made a statement saying, “The people who approve the drug in the first place, within the FDA, and take pride in the fact that they’ve brought a drug to the market - that is their baby. This is their drug.” he says this because the

5. Predict: How often do you think the patient should take a pill? Every 2 to 4 hours

1. There are a number of types of materials and equipment needed for the administration of medication via the different routes. They all serve a type and purpose these include:

In today’s business world, production cost was an increasing concern for companies working to stay competitive in the global marketplace. The top management must search for a global solution to drive down costs and reduce difficult activities associate with inventory management and production management. Global sourcing aimed to exploit global efficiencies in the delivery of services and goods across geopolitical boundaries, including low cost skilled labor, low cost raw materials, tax benefits, and price breaks. Whelan Pharmaceutical was the best example to illustrate how the company chose the best manufacturing site for global sourcing from different perspectives.

When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that’s not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don’t know how many times I’ve asked my mom or dad how come the doctors don’t get together and make a “miracle” drug that could heal anything and everything. It wasn’t until the age of 15 when my grandmother was diagnosed with breast cancer that I understood why it took so long for others to heal and the process that they had to endure in order to be healthy again. Shortly after my grandmother’s diagnosis, I started looking into what it would take to get a drug that would cure cancer through the approval process on the shelf to save some many others just like my grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards chemotherapy and radiation. Although I wanted something to heal my grandmother fast, chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high school. I went to almost every appointment with her to watch how it helped strengthen but also watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my

There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment.

The problem that is depicted in the film is the conflict of interest between the Food and Drug Administration (FDA) and pharmaceutical companies. It shows that the relationship these two entities have, has posed danger to the U.S public. Before a new drug is allowed to be purchased by consumers, it must go through FDA approval for safety. The film explains that the drugs that are getting approved by the FDA are actually not safe. The FDA is being paid or bribed by pharmaceutical companies to expedite the approval process. The quick process allows pharma companies to get their new drugs out in the market much faster. Every day that passes and a drug is not approved, is a big loss of money for the companies. The other problem is that doctors are prescribing these drugs to patients. Doctors are trusting the FDA system and the pharma companies to provide safe and effective drugs. Doctors are fooled by pharmaceutical “detailers” that are hired

Accelerated Approval process -drugs that fulfill an unmet need in a serious condition, and that can establish an effect on a substitute indicator or intermediary clinical endpoint can get early approval before providing full clinical data, but company has to make a commitment to conduct phase IV confirmatory trials (FDA, 2016).

What would you do if you had to suffer every day from a life threatening illness that was debilitating and incurable? Over nine hundred million people throughout the world die each year because of incurable diseases such as cancer, HIV, and AIDS (What par 1). The number of people that suffer from these varying illnesses is slowly increasing, but the use of pharmaceutical drugs is helping to solve this problem. “The pharmaceutical and medicine manufacturing industry has produced a variety of medicinal and other health related products undreamed of by even the most imaginative apothecaries of the past” (Pharmaceutical par 1). Every day, millions of lives are saved with the use of these medications, and they allow these innocent people to live ordinary lives (Pharmaceutical par 1). According to William Lang, Vice President of policy and advocacy for the American Association of Colleges of Pharmacy, “There’s an increasing number of people with chronic illnesses, and the primary management tool available for dealing with chronic illness is medication” (Thompson par 10). While some take medications for simple health issues such as headaches, the flu, or minor colds, others use them to aid in the treatment of more serious illnesses such as pneumonia, cardiovascular disease, diabetes, autoimmune disorders, and cancer (Pharmaceutical par 2). Doctors and hospitals prescribe hundreds of thousands of new medications each day to patients, and many of these prescriptions range in cost

The Drugs Technical Advisory Body (DTAB) is a technical body with the Director General of Health Services as the chairman and Drugs Controller of India as the member-secretary. It has to be consulted before any rule is amended or introduced.