So today, FDA posted minutes of its October 29, 2020 GDUFA III negotiation meeting with industry.  Nice to see that the FDA is keeping us informed of pertinent issues being discussed.  Here is the entirety of the minutes absent the attendees and the date of the next meeting.


Industry provided their response to FDA’s proposals to advance earlier approvals of generic applications.  Industry suggested possible opportunities for enhancing communications between FDA and industry.

Interesting how detailed the discussions are.  You can really get a sense of the issues and where everyone stands.  Oh, by the way here is the discussion portion of the October 22, 2020 meeting.


FDA and Industry continued clarifying the proposals to advance earlier approvals of generic applications.  Industry will inform FDA of its position with the proposals in the coming weeks.

I feel like I am in the room with the detail of this coverage of these negotiations.

You can see the minutes of all of the meetings here.

Now I see! Look, I know that the negotiations are designed to be somewhat confidential, but don’t you think the industry has a need to know what is being discussed in a little more detail?  While the two previous meetings had a little more color, please remember that the industry is footing the bill for GDUFA and we don’t expect it to cost less than GDUFA II.  The minutes of the negotiations appear like ordering from a menu that says, we have a lot of stuff, but if you guess wrong, you don’t get to eat!

How about it, negotiators? Just a bit more flesh on the bones would be nice!