What is the purpose of the Pre-Submission (Pre-Sub) meeting with the FDA?

The purpose of the Pre-Submission (Pre-Sub) meeting with the FDA is primarily to obtain feedback on proposed clinical study designs and regulatory strategies. This meeting serves as a platform for sponsors to engage directly with FDA staff to discuss planned studies or submissions before they are formally submitted. By doing so, sponsors can clarify regulatory expectations and receive valuable insights that can enhance the design of their clinical trials and overall regulatory strategy. This early interaction helps to ensure that the sponsors align their plans with FDA requirements, potentially reducing the risk of delays or issues later in the drug development process.

Engaging in this dialogue allows for the identification of any concerns or suggestions the agency may have regarding the proposed studies, which can be instrumental in refining the approach to data collection, trial design, and compliance with regulatory guidelines.

In contrast, finalizing drug labels and marketing approvals occurs later in the process after data has been collected and a submission has been made, and the FDA does not engage in negotiations over drug pricing or implement post-market surveillance strategies during this pre-submission interaction. These aspects are separate functions that fall outside the primary aim of obtaining pre-submission feedback.