For biological drug products regulated by CBER, how many days does the FDA hold a Type C meeting after receiving a sponsor's meeting request?

The FDA has established timelines for interactions with sponsors regarding biological drug products, particularly through the meeting requests outlined in their guidance documents. For Type C meetings, which are intended for discussions on specific product-related issues, the FDA aims to hold these meetings within 75 calendar days of receiving a sponsor's request.

This timeline is crucial as it allows sponsors to receive timely feedback on their development programs or regulatory submissions. The 75-day period reflects the FDA's intention to provide structured communication while still allowing them sufficient time to prepare for the meeting, which may involve gathering relevant data, analyzing the requests, and coordinating with the appropriate reviewers.

This timeframe is an important aspect for sponsors in planning their development timelines and ensuring they can address regulatory considerations effectively in line with FDA guidance.