As part of any product development it is of paramount importance to build constructive relationships with Regulatory Agencies. If you intend to bring your product to the USA market you should involve the Food and Drug Administration (FDA) as soon as possible into your product development. This is especially important if you are a Small Enterprise and/or you are about to develop a novel drug, for which there are no predecessors or guidelines developed.
In order to properly involve the FDA you should thoroughly understand what kind of FDA interaction possibilities exist and what they are used for.
Generally, FDA offers both formal and informal meetings in order to offer support and facilitate complete and fileable application.
Important to note is that they are free of charge.
Informal meetings can be scheduled with the FDA, subject to their resource constrains, and represent usually a preliminary, non-binding FDA advice either on general aspects of certain regulatory topics (e.g. informal meetings with the Office of Orphan Products Development-OOPD) or offer a bit more specific preliminary Agency views at an early stage of development prior to a pre-IND meeting (e.g. INTERACT meetings with CBER).
Formal meetings with the FDA are extremely important, can significantly impact the product development timelines and bring your product earlier to the market.
The timing and the type of the formal meeting with the FDA will depend on the phase of the drug (product) development you are currently in.
There are four distinct types of meetings.
Type A meeting
Type A Meetings are relatively rare.
This type of meeting is usually used to discuss and address:
It is advisable as a requester to contact the review division in advance and discuss your request.
Type A meeting will be scheduled within 30 days from receipt of meeting request.
Type B End-of-phase (EOP) meeting
The type B meetings are requested at the end of developmental phase (EOP) and prior to progression to the next phase (e.g. End-of-phase 2 meeting).
Type B meeting
Further examples of Type B meetings are:
Meetings regarding risk evaluation and mitigation strategies (REMS) or post-marketing requirements that occur outside the context of the review of a marketing application,
Post-action meetings requested by the sponsor 3 months or more after an FDA regulatory action other than an approval
Pre-IND (Pre-investigational new drug application) and pre-NDA (Pre-new drug application) / pre-BLA (pre-biologics license application) meetings belong to Type B meetings.
Meetings held to discuss the overall development program for products granted breakthrough therapy designation status.
Type B meeting will be scheduled within 60 days (70 days for EOP) from receipt of meeting request.
Type C meeting
Any meeting other than a type A or type B regarding the development and review of a product.
Type C meeting will be scheduled within 75 days from receipt of meeting request.
How to prepare for the meeting with the FDA
Good preparation for the meeting should ultimately help your team be more confident and better organized prior to and during the meeting. Prior to submitting a meeting request to the FDA, you should plan thoroughly, decide on activities that should be done prior to the submission and create clear timelines.
It is absolutely crucial to agree on the roles and responsibilities well in advance to avoid awkward situations during the meeting.
Presence of the regulatory affairs and scientific experts is mandatory. You should be very specific about the scope of the meeting and have clear expectations.
There are three meeting formats:
When scheduling a meeting with the FDA a written request (paper or via the electronic gateway) should be submitted. If you are not sure which type of meeting to request, contact your FDA Regulatory Project Manager (RPM) for assistance.
This information should be included in the Meeting request:
Application number (if applicable)
Chemical name and structure
Proposed indication(s) or context of product development
Type of meeting being requested (that is, Type A, Type B, or Type C). If a Type A meeting is requested, the rationale and meeting package should be included. FDA will generally deny requests for Type A meetings that do not include the meeting package in the original request.
Assigned FDA RPM will reach out to sponsor to agree on the date and time of the proposed meeting.
The Briefing package should be sent to the RPM.
The Briefing package should:
Have a table of contents
Have a list of focused questions and your position to each question (prepared by your company)
Be clearly organized with tabs
“Not too big, not too small” (usually between 20-50 pages + appendices)
Submitted on time and in adequate number of copies
Avoid vague open-ended questions
FDA will review you Briefing package and they will have at least one internal meeting to discuss it. Preliminary answers will be sent to you 24-48h prior to the meeting. This period can be very intense since your team should work hard to assess what topics should be further discussed with the FDA in the upcoming meeting, what topics require more data and what topics can be considered resolved. On top of that you should prepare a presentation outlining your positions to the remaining open topics, let your team agree to it and rehears it. All this is packed into 1-2 days before the meeting, making this period quite stressful. It is therefore extremely important to have experienced Regulatory experts leading this process.
During the meeting
Here are some tips that can help you during the meeting with the FDA:
Arrive early (there are security procedures to be followed before you can enter a meeting room)
This is your meeting, you should lead it and use the time wisely
Address any concerns from the preliminary answers sent by the FDA
Summarize all agreements, key discussion points and action items
Make sure that all your questions are answered prior to leaving
Always be polite, don’t lie, don’t promise things you can’t fulfill
Perform a “de-brief” meeting with your team, preferably right after the meeting with the FDA (this will help you create your meeting minutes)
After the meeting
Official meeting minutes will be issued by FDA within 30 days.
Review the minutes and clarify any discrepancies.
Follow up on any commitments, requests and action items.
Next to the above-mentioned formal meetings there are other meetings scheduled during the NDA review phase (an applicant Orientation Presentation meeting (optional), post mid-cycle and/or late-cycle meetings, Advisory Committee meetings, or Agency can schedule other meetings based on an identified need) or the FDA can request a formal meeting at any time during your product development.
You should be ready to adequately and quickly respond to the FDA requests and having experienced and knowledgeable Regulatory team is your key to success.