I’m working on a Health & Medical exercise and need support.
What regulatory pathway under the FD&C Act or Biologics Act was the product submitted under?
What is the indication statement?
What is the mechanism of action?
Is there a black box warning? If so, why. What is the concern?
How many clinical studies were described in the package insert?
How many patients are described in section 14?
How is the product supplied (section 3)?
What are the most common adverse reactions as listed within the PI?
What is the storage conditions of the product?
Who is the manufacturer and who is the NDA holder?
Is the product approved anywhere else globally, and if so, what are the main differences in the labelling?
Remember the disease state is Alzhiemer and our product is
Aricept (Donepzil). As said by you, 4 pages or above needed
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