Question No 3:
Which of the following states is NOT true with respect to both Investigational New Drug (IND) Applications and Inverstigational Decice Exemptions (IEDs) for significant- risk products?A. The investigational product must be manufactured in full compliance with CGMP
B. Clinical studies must be reviewed and approved by an Institutional Review Board
C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise.
D. The application must include and environmental impact statement that contains a claim for categorical exclusion or and environmental assessment
Answer: A
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