Health Medical Homework Help

In thinking about the pre-IND phase, it is important to consider what information is needed from the FDA, and what information you can provide to the FDA ensure the objectives are understood by the Agency.

Using information and data found in the public domain regarding your chosen disease state and chosen product, prepare the pre-IND meeting request to discuss the start of a Phase 3 clinical study in the United States.  This assignment presumes that other clinical trials were conducted ex-U.S., and not previously filed to an IND.

The contents of the meeting request should follow that indicated in the guidance provided under Supporting Materials.

The questions the Sponsor wishes to ask should be included in the meeting request, as this is the basis of whether or not the FDA will grant the meeting.

When writing the meeting request, think about the two following points:

What specific questions would you ask the FDA as a priority before embarking on a costly clinical study?

What would you want the FDA to know about this study which convinces them that this meeting and clinical program is warranted and important?

https://www.fda.gov/media/109951/download

Remember our disease is Alzheimer

Product is Donepezil (Aricept)

Donepezil is drug name and Aricept is final product name which contains Donepezil.