Regulatory Open Forum

Dear Community,

Has anyone had experience with being granted a Type D meeting in the form of a teleconference?  In my experience to date, I have only seen WROs granted.  I would like to request a meeting that qualifies for Type D, but would prefer a teleconference format vs. WRO, so I am considering requesting a Type C meeting to maximize probability of a teleconference. 

Thank you.

Monique

Dear Monique-

I have not been involved with the formal request for a Type D meeting. I have, however, participated in pilot meetings that led to the development of Type D meetings. Nevertheless, based on my experience on both sides of the aisle, the choice between teleconference and WRO depends less on the format of the meeting and more on the scope posed by the sponsor. The background/purpose of the meeting and questions from the meeting request (and possibly a backgrounder for Type D because it has to be submitted at the time of the meeting request) should be persuasive enough for the FDA to believe that discussion is required. In my experience, it should involve at least one unique development issue that is in the gray area, e.g., we agree/disagree but..... If everything is a cookie-cutter response or totally unacceptable proposal, then it ends up in WRO.

It is all about meeting requests and background writing. It is a bit of an art, but it also starts with a true drug development problem. I hope this helps.

Dear Community,

Has anyone had experience with being granted a Type D meeting in the form of a teleconference?  In my experience to date, I have only seen WROs granted.  I would like to request a meeting that qualifies for Type D, but would prefer a teleconference format vs. WRO, so I am considering requesting a Type C meeting to maximize probability of a teleconference. 

Thank you.

Monique

Dear Pravin, 

Thank you for your reply.  This is what I would have assumed, yet our experience with close to 10 Type D meetings is that all have been WROs, so I began to question if this was the default for Type D meetings.  I greatly appreciate your perspective from both sides of the aisle.  I will update this post if we are granted a TC for a Type D meeting. 

Thanks again,

Monique

Dear Monique-

I have not been involved with the formal request for a Type D meeting. I have, however, participated in pilot meetings that led to the development of Type D meetings. Nevertheless, based on my experience on both sides of the aisle, the choice between teleconference and WRO depends less on the format of the meeting and more on the scope posed by the sponsor. The background/purpose of the meeting and questions from the meeting request (and possibly a backgrounder for Type D because it has to be submitted at the time of the meeting request) should be persuasive enough for the FDA to believe that discussion is required. In my experience, it should involve at least one unique development issue that is in the gray area, e.g., we agree/disagree but..... If everything is a cookie-cutter response or totally unacceptable proposal, then it ends up in WRO.

It is all about meeting requests and background writing. It is a bit of an art, but it also starts with a true drug development problem. I hope this helps.

Dear Community,

Has anyone had experience with being granted a Type D meeting in the form of a teleconference?  In my experience to date, I have only seen WROs granted.  I would like to request a meeting that qualifies for Type D, but would prefer a teleconference format vs. WRO, so I am considering requesting a Type C meeting to maximize probability of a teleconference. 

Thank you.

Monique