The FDA and industry representatives reported on two more negotiation sessions held on March 4, 2026 and March 6, 2026, the minutes of which are reported in full here and here, respectively. There was some progress—agreements were made on certain topics, and discussions were foreclosed on others—but it looks like we are getting closer to an agreement […]
As is the case with most negotiation sessions, no agreements were made at this time on the issues discussed. This is a back-and-forth process and the norm as negotiations proceed; the ultimate FDA decision-makers must weigh in on the issues prior to agreement. The full minutes of the meeting can be found here, and some […]
Traditionally, user fee negotiations, whether for PDUFA, GDUFA or BSUFA, have maintained that the negotiations are essentially for fee-for-service contracts. What this means is that the industry provides fees and the FDA provides services for those fees. The negotiations usually end with the commitment letter and any statutory changes that result from the negotiations. For […]
The GDUFA IV meeting held on January 7, 2026 (here) was a bit of a what-if session with the FDA introducing a few new concepts for consideration in the negotiation process. First, the FDA suggested waiving GDUFA facility fees for a three-year period for new domestic manufacturing facilities that break ground to manufacture generic drug products or […]
Lachman Consultant Services, Inc. is proud to be a Gold Sponsor of the 2023 PDA Robotics and Automation Conference. Taking place on Wednesday, May 3rd and Thursday, May 4th, 2023, in Amsterdam, The Netherlands, the two-day gathering builds a roadmap to digitization designed for drug manufacturing. This annual conference is designed to catalyze the transition […]
The CDER Small Business and Industry Assistance (SBIA) presented a two-day seminar on April 12-13, 2023, celebrating the first 10 years of GDUFA. With the Office of Generic Drugs and industry now operating under the third iteration of GDUFA, the presentations by FDA Agency covered a lot of ground in an effort to highlight the […]
Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]
The Federal Register today provided the snapshot of generic drug user fees for FY 2022 (here) and the flash may blind you as some new fees have popped up and the program fees have actually decreased, but not by much! FEE CATEGORY FY 2021 Fees FY 2022 Fees % Change Applications Abbreviated New Drug Application […]
The trade press has reported that at least three of the major four user fee acts (UFAs) are close to wrapping up negotiations for the new five-year reauthorization period beginning in October 2022, but we have not heard where GDUFA III is in the process. As noted in a previous post (here), we wondered why […]
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. Discussion Industry provided their response to FDA’s […]
