If a manufacturer wants to sell a product that has the ability to alter the physiology of the person when the product is swallowed, inhaled, rubbed in or otherwise applied, laws in the United States and Europe control the sale of this product.
1. What is regulated by the United States Food and Drug Administration?
2. Why are products regulated by the FDA?
3. Which documents does the FDA require from a manufacturer before it accepts a IND?
4. What role does the CDC have in regulating products sold by manufacturers?
5. Which documents are required by the FDA for it to accept an IND?
6. Which products require microbiology reports included in an IND and why?
7. What are the 3 broad classes of information needed in an IND?
8. What is the point of an IND? Why do one at all, why not get straight on with the NDA?
9. Read this document about safety requirements for a IND application click here. When do problems with the manufactured product have to be reported to the FDA; what sort of problems trigger these reports; how are these reports made?
10. Where does the IND fit into the common technical document?
11. You are in a lab and have isolated a powder, added it to a piece of chicken. After 5 minutes, the fat was dissolved, but the protein and structure unchanged. What are the steps that are needed to be taken to bring this drug to market as a therapy for cleaning out cholesterol from arteries?
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