What is an Investigational New Drug (IND) application?

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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).

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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