Submission & Approval

Pre-Submission Meeting(Pre-Sub)

A meeting with FDA to discuss regulatory questions before submitting a marketing application.

Usage Examples

The Pre-Sub addressed Phase 3 endpoint selection.
FDA agreed with the proposed 510(k) predicate device.
Type B meeting minutes documented FDA recommendations.

What is Pre-Sub?

Pre-Submission meetings (Pre-Subs) allow sponsors to obtain FDA feedback on specific questions before submitting marketing applications. For drugs, these are called Type A, B, or C meetings based on timing and purpose. For devices, Pre-Submission meetings are defined in FDA guidance.

Meeting requests include proposed agenda, background information, and specific questions. FDA provides written feedback, which while not binding, is highly influential for submission strategy. Pre-Subs can address study design, endpoints, regulatory pathway, submission format, and other critical questions.

Effective Pre-Subs require focused, well-reasoned questions with supporting data and proposed approaches for FDA feedback.

Regulatory Context

This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 312, FDA MEETING GUIDANCE.

FDAICHEMA

When This Matters

The Pre-Sub addressed Phase 3 endpoint selection.
FDA agreed with the proposed 510(k) predicate device.
Type B meeting minutes documented FDA recommendations.

Common Mistakes

Treating submission readiness as a formatting-only check without lifecycle validation.
Using outdated guidance references across modules and summaries.
Missing cross-functional review between RA, CMC, and quality before submission.

Related Regulations

21 CFR 312FDA MEETING GUIDANCE

Frequently Asked Questions

Type B meetings are pre-NDA/BLA, end-of-Phase 2, pre-Phase 3, or other critical meetings. FDA must respond within 60 days of request for drugs. They're the most common formal meeting type.

FDA feedback is not legally binding but represents the agency's current thinking. Deviating from Pre-Sub guidance without justification may lead to review issues.