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October 4, 2022

Biotechnology and The Regulatory Environment Paper

Biotechnology and The Regulatory Environment Paper

1. For quiz 3 please answer the following questions in 2-3 paragraphs and provide references where applicable.

During an inspection of New Drug Biologics, the FDA inspector observed multiple problems with documentation and quality oversight that are a violation of current good manufacturing practices (cGMPs). Based on the Week 9 readings, what is the process for notifying New Drug Biologics of these observations? How is New Drug Biologics able to respond after they have been notified of the observations?

If I were a competitor of New Drug Biologics, would I be able to find out what the FDA observed during the inspection? If so, how?

2) In your opinion, does the source of funding for clinical research affect the outcome/results of the trial?

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