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FDA Introduces “New” Formal Meeting Format

April 9, 2015 | Mark A. Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Operations, Drug Development Consulting

We previously blogged (here) on the FDA’s release of a draft guidance document that revises their 2009 guidance on formal meetings with sponsors and applicants. One of the significant changes being made is the addition of a new meeting format option – a so-called “written responses only” meeting.

    Have you seen this header already on FDA meeting correspondence?

purpleThe wording of your questions and the background information you provide to the FDA are critical if you are granted one of these “meetings.” Meeting Granted Written Responses Only
Although touted as a new meeting format in the revised guidance, IMPACT has been seeing use of the “Meeting Granted Written Responses Only” format for some time now. It’s a bit of a non sequitur, isn’t it … “Yes, we are granting you a meeting, but we aren’t actually going to meet with you.” Instead, you get written responses to the questions submitted in your Information Package, and that formally ends the procedure.

The new draft guidance states that this meeting format may be appropriate for certain Pre-IND and Type C meetings, at the discretion of the Agency. The draft guidance also states that sponsors and applicants can request this format, as opposed to a face-to-face meeting, videoconference, or teleconference.

Better Than No Meeting at All
faceAlthough certainly better than being denied a meeting altogether, being granted a written responses only meeting is not ideal. If the written responses you receive from the FDA are not totally clear, there is not a formal opportunity, like at a face-to-face meeting, to ask clarifying questions, let alone ask the follow-up questions that we all like to try to engage the FDA in if we can.

This highlights the need to word your questions correctly, as well as the importance of providing a complete Information Package to support those well-worded questions.

FDA can only respond to you meaningfully if they understand what you’re asking AND you give them enough background information and data on which to base an answer.

Unintended Consequences?
It will be interesting to see if the FDA gets a flood of requests for “Type C Meeting – Written Responses Only.” Before this option was available, general development questions could be submitted to the FDA as an IND amendment – “Request for Agency Feedback.” Since the FDA is not obligated to respond to these, and if they do, there is no mandated timeframe, why not try a getting a guaranteed response and a 75-day clock by requesting a written responses only meeting?


Image courtesy of Stuart Miles

Comment Period Still Open
Remember, the revised formal meetings guidance document is not final yet. Comments and suggestions regarding the draft are being accepted by the FDA through June of this year. You can submit written comments to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.


Category: | Regulatory Affairs, Drug Development Consulting
Keywords: Formal FDA Meetings, FDA Meeting Guidance

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