United States Food And Drug Administration

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Introduction Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms. As a Type 1 Diabetic, it is easy to understand the consumer’s frustration when it comes to hearing about a new device or drug that will make living with diabetes much…show more content…
This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug. The First Step: The Discovery Process The discovery process is the preliminary research that an organization or research team will engage in before they even begin to look at a new drug on a molecular level. “The discovery process includes the early phases of research, which are designed to identify an investigational drug and perform initial tests in the lab” (PhRMA, 2015). In order for the researchers to know where to start with trying to create a new cure or treatment, they first have to do an in depth analysis of the disease so that they can fully understand it. To begin with, the research team will need to choose a specific molecule that they would like for the new drug to target. “Target validation is crucial to help scientists identify the most promising approaches before going into the laboratory to develop potential drug candidates, increasing the efficiency and effectiveness of the R&D process.” (PhRMA 2015). Without identifying the target, they would be going into a project without a plan of action or an end goal in mind. The target of a drug is similar to the vision of a company. The vision is the overall goal or purpose of a company. For example, the vision statement of company XYZ states “our vision is to lessen the burden of diabetes management by developing alternative
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