A Type C FDA meeting is a formal interaction between the FDA and a drug or biologic sponsor covering any development question that doesn’t fall into the Type A or Type B categories. It’s the catch-all. If your question isn’t an urgent safety or clinical-hold issue (Type A) and isn’t tied to a major development milestone like an end-of-phase-2 conference (Type B), it’s almost certainly a Type C. The FDA targets scheduling within 75 calendar days of receiving the request, which is slower than Type A or B but still a reliable way to get the agency’s position on record.
How Type C Fits Against Type A and Type B
The FDA’s formal meeting system sorts sponsor interactions by urgency and purpose, so understanding Type C means understanding what it isn’t.
Type A meetings are reserved for the most time-sensitive situations: resolving a clinical hold that has stopped a trial, addressing disputes that have gone through the division level, and handling special protocol assessments. The FDA targets scheduling within 30 days.
Type B meetings mark the major milestones in a product’s lifecycle. They include pre-IND meetings, end-of-phase 1 meetings for accelerated programs, end-of-phase 2 / pre-phase 3 meetings, pre-NDA and pre-BLA meetings, post-action meetings requested at least three months after a complete response letter, and breakthrough therapy meetings. Type B meetings get a 60-day scheduling target.1Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products – Guidance for Industry
Type C meetings are defined simply as any meeting that does not qualify as Type A or Type B.2Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants That breadth is what makes them useful. Questions about manufacturing process changes, interpreting non-clinical data, or clarifying labeling requirements don’t fit the milestone-driven Type B framework but still deserve a formal, documented FDA response. Type C is where those conversations happen.
When to Request a Type C Meeting
A Type C makes sense whenever you have a well-defined question that needs FDA input but doesn’t align with a major development milestone. Common scenarios include discussing a novel analytical method, working through unexpected findings in preclinical data, clarifying post-marketing commitments, or getting feedback on a proposed labeling change. The connecting thread is that you need the agency’s position in writing, through official meeting minutes, before you can confidently move forward.
Timing matters less for Type C than for Type A or B. You can request one at nearly any stage, from early development through post-approval. That said, a poorly timed request wastes everyone’s calendar. Exhaust informal channels first. If a phone call or email with your review division could resolve the question, a formal meeting adds overhead without adding value. Save Type C requests for questions where you need the FDA to commit a position to the record.
When Type C Doesn’t Apply
The Type A/B/C framework is specific to drugs and certain biologics reviewed by CDER and CBER. It doesn’t cover every FDA-regulated product.
Medical device sponsors use a separate system called the Q-Submission (Q-Sub) program. Q-Subs cover pre-submissions for device development questions, IDE applications, 510(k) submissions, De Novo requests, and PMA applications, but they aren’t categorized as Type A, B, or C.3Food and Drug Administration. The Q-Submission Program – Guidance for Industry and Food and Drug Administration Staff
Generic drug applicants also operate under their own system. Under GDUFA III, pre-ANDA interactions are categorized as Product Development (PDEV) meetings or Pre-submission (PSUB) meetings rather than Type C meetings.4Food and Drug Administration. Overview of Pre-ANDA Meetings Under GDUFA III
What Goes Into the Request and Briefing Package
A Type C meeting request has two components: the initial request letter and the briefing package. They can be submitted together or separately.
The request letter should include your product name, application number if you have one, the proposed indication, a brief statement of what you want to discuss and why, your proposed agenda, the specific questions you want the FDA to address, who will attend from your side, and your preferred meeting format. Format options include teleconference, videoconference, in-person, or written response only.5Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
The briefing package is where the real work happens. It gives the FDA everything it needs to prepare substantive responses: background on your product, a summary of the relevant data, the rationale behind each question, and any proposed approaches you want feedback on. The briefing package is due at least 47 days before the scheduled meeting date.6Food and Drug Administration. OTP Type C Meetings Missing that deadline can result in your meeting being postponed or canceled, so build the timeline backward from your target date.
The quality of your questions largely determines the quality of the meeting. Vague questions like “What does FDA think about our clinical program?” invite vague answers. Specific, binary-friendly questions like “Does FDA agree that a single pivotal trial with the following endpoints would support approval?” force the agency to take a clear position. Experienced regulatory teams draft questions so that even a yes-or-no answer is actionable.
Timelines You Can Expect
The FDA follows defined timelines for Type C meetings, measured in calendar days rather than business days:
- Response to your request: 21 calendar days from FDA receipt. The agency will grant or deny the meeting and, if granted, specify the format and date.
- Meeting held or written response issued: 75 calendar days from FDA receipt of the request.
- Preliminary responses to your questions: no later than 5 days before the meeting, so the live discussion can focus on clarifying or negotiating rather than hearing positions for the first time.
- Meeting summary issued: 30 calendar days after the meeting. The FDA’s version is the official record.6Food and Drug Administration. OTP Type C Meetings
The 75-day window is a target, not a guarantee. A late or incomplete briefing package can push the meeting back. Submitting a strong package on time is the single most reliable way to keep the schedule.
Written Response Only as an Alternative
Not every Type C interaction needs a live meeting. Sponsors can request a Written Response Only (WRO) format, and the FDA sometimes suggests it when the questions are narrow enough to resolve on paper. In a WRO, the FDA provides written responses within the same 75-day window that would apply to a scheduled meeting.6Food and Drug Administration. OTP Type C Meetings
WRO works when your questions are specific, your briefing package tells the full story, and you don’t need real-time back-and-forth with reviewers. The briefing package still needs to be submitted 47 days before the target response date, and the same documentation standards apply. Where WRO falls short is on complex or ambiguous issues where a live discussion and follow-up questions would meaningfully change the outcome.
After the Meeting: Minutes and Disagreements
The FDA issues the official meeting summary within 30 calendar days. This document is the binding record of what was discussed and any positions the agency took. If you walked away believing the FDA agreed to something, it only counts if it appears in those minutes.
Sponsors sometimes find that the minutes don’t reflect what they heard in the room. The FDA’s formal dispute resolution guidance states that advice in meeting minutes is not a regulatory action and cannot be formally appealed through the standard dispute resolution process.7Food and Drug Administration. Formal Dispute Resolution – Sponsor Appeals Above the Division Level Sponsors are also not bound by meeting advice. You can follow it, or you can take a different approach if it satisfies the applicable statutory and regulatory requirements. If you disagree with the FDA’s position, one option is to request another meeting and ask that the next level of management attend. Requesting a follow-up Type C specifically to revisit a contested issue is an accepted use of the process.