Week Writing Assignment

Instructions

You are a regulatory associate at a private firm asked to assess the regulatory issues associated with a clients proposed vaccine and diagnostic kit against Lyme disease.You will need to draft a 2-3 page written memo expanding upon the scientific and historical background of the vaccine and any regulatory issues you anticipate for the development of a vaccine and a diagnostic. (Re-writing this question and bibliography do not apply to page count) Hint: 1-2 paragraphs background, 2 pages for issues, and a 1 paragraph conclusion.Please include any specific regulatory requirements for submission to the regulatory agency (ie-the company will need to submit xyz as part of their IND under Sec. 312.21 Phases of investigation). Our FDA class notes will be useful.I have included in the Course Content section a few things that will assist you, including a patent and a couple papers. Please include at least 5 other sources, citing them as primary or secondary.Question 2: Discuss the history of regulation of biotech crops in the United States, and by whom they are regulated. For full credit, please be specific regarding the agencies (and divisions within agencies), and specific guiding statutes and provisions that direct review. I strongly encourage you to provide an example of a specific product or products that illustrate your response. There is a 1-page limit (not including original question and references)

Answer

LYMErix: Vaccine against LymeScientific backgroundLyme is one of the diseases that is caused by a bacterium that is spread by ticks. The prevalence of Lyme is high in various parts of the continent such as the U.S. and Europe. For instance, the US Centers for Disease Control and Prevention (CDC) recorded that about 30,000 people contract Lyme every year in the U.S. It is estimated that about 300,000 could be affected by Lyme every year in the United States and more than twice this figure elsewhere. Following these high infections, it was necessary to have a vaccine against Lyme, although it was mild and curable.LYMErix was one of the human vaccines that was developed against Lyme. The vaccine worked quite differently from the rest of the vaccines. In most cases, vaccines work through impro...
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