U.S. Food and Drug Administration
Protecting and Promoting Your Health
Any meeting other than a type A or type B regarding the development and review of a product.
- A written response to questions posed in pre-IND or Type C meeting requests may be requested by the sponsor
- FDA may determine that a written response would be the most appropriate means for responding to a meeting request
- FDA shall notify the requester of the date it intends to send the written response
- FDA shall provide this notification within the specified time frame for responding to the meeting request
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