BTMN 636 UMUC Biotechnology and The Regulatory Environment Discussion

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Question 1 (50%): You are a regulatory associate at a private firm asked to assess the regulatory issues associated with a client’s 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 (30%): 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).

Question 3 (20%): Short answer, 1 paragraph each. Please cite where you found answers. (Wikipedia is not a valid source).

a. What is an Investigational New Drug (IND) application?

b. What is a New Drug Application?

c. What is an Abbreviated New Drug Application (ANDA)?

d. What is ICH?

e. What products do the EPA and USDA regulate

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