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505(b)(2) – Part 3: Pre-IND submission & meeting

Before filing an IND, it is desirable (we counsel imperative) to have a pre-IND meeting with the FDA.  The goal is to get FDA’s concurrence with the proposed development plan and regulatory submission pathway.  The steps for this meeting (known as a Type B meeting) include:

  1. Prepare a pre-IND submission package.

This package outlines where we will be obtaining information for all sections of an NDA, what we feel we will get from existing public information and what the FDA will need from the sponsor.  Much of this information comes from the Assessment Report. For the information needed from the sponsor, we will propose synopses of the clinical studies.  We will outline the CMC development plan and the basis for requesting the 505(b)(2) submission pathway.

  1. Prepare a pre-IND meeting request with questions to be addressed and proposed FDA attendees.

After the Assessment report and pre-IND submission package is prepared, Camargo and the client will generally meet to discuss any significant questions that neither party can resolve. These regulatory-related questions will be distilled into positions that can be presented to FDA for agreement.  Since the meeting can last only 1 hour, there must be a very good management of these questions.

It is important to request the right attendees – FDA will not usually decide these for you.  It is important to get the right discipline present to answer the question(s).

The usual rules apply: never ask a question you don’t want an answer to (public companies especially); never ask a question you already have an answer to; never ask a question that asks the FDA to speculate (wastes both parties time).

  1. Send in the pre-IND meeting request and co-ordinate meeting dates.

The pre-IND meeting usually will be granted within 60 days (some FDA divisions can’t meet this timeframe).  Getting calendars to match is not trivial.  Yet, the FDA welcomes these meetings as a cost and time saver for the future and will endeavor to schedule a convenient time.

  1. Have the meeting.

Or maybe not!  The FDA will review the pre-IND submission package and questions.  FDA will respond in writing to all of the questions before the meeting (but often by fax within 24 hours of the meeting).  If during their review, the FDA project manager starts to see that no controversy arises, the sponsor may be notified that a meeting is not necessary unless the sponsor demands one.  Camargo has seen this happen several times (just this week in fact).  If there is just a minor need for a meeting, FDA may suggest a teleconference (we’ve done these too!).

  1. Review and concur with FDA meeting minutes, resolving any discrepancies.

After the meeting (or telecon) the FDA will send out minutes, including their previous written response.  The sponsor can request clarification or revisions of these minutes.  Usually this process can take a few weeks.

Think for a moment how valuable your drug is at this point.  You have knowledge of where all of the NDA information is coming from, you have an outline of the needed studies with timeline and estimated costs.  And, you have the FDA’s concurrence.  You cannot image how few other companies are in this position.  Really.  Camargo sees many companies without pre-IND’s, lacking even a good idea of the required studies.  Your investors will be impressed.  Better yet, you literally can take the package to the bank (or investors) for funding.

By the way, you may notice that you don’t even have to have a physical product up to this point – just an idea.  How cool is that?

Next up – If needed, Pre-clinical.  Otherwise, IND filing.