The User Fee negotiations are still underway and those discussions must be finalized soon or you may not have many folks to speak to at FDA. Yes, there is some carryover money but no one knows for sure how employees will react if pink slips go out. It now looks like September 15th will be […]
Outsourcing facilties are compounding facilities that are registered by the FDA and subject to inspection. The fee structure is rather simple, with facility fees and reinspection fees only. The fee rates for FY 2023 will go into effect on October 1, 2022. A chart comparing the FY 2022 and FY 2023 fees is provided below: FY 2022 […]
In the prepublication of the Federal Register this morning, the FDA announced the Animal Drug User Fee Rates (here) and the Animal Generic Drug User Fee Rates (here). Some of the fees increased significantly while others decreased. Fee variations are based on the projected number of applications, establishments, and products, as well as inflationary calculations. […]
In an article titled “A Bipartisan Case Against US FDA User Fees?” published in the Pink Sheet on July 11, 2022, Michael McCaughan discusses two of the no votes from senators on reauthorization of the user fee program. McCaughan writes that Senators Richard Burr and Bernie Sanders “expressed concern that the increasing fees contribute to […]
The FDA published the OTC User Fee rates for FY 2022 today These rates were announced this morning in a Federal Register notice (here) and cover fees for OTC manufacturing facilities, contract manufacturing organizations (CMO), and OTC monograph order requests (OMOR) for which there are tier 1 and tier 2 requests. A comparison of the FY […]
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 FDA published its first arrears list for failure to pay FY 2021 Over-the-Counter Monograph User Fee Act (OMUFA) facility fees. Invoices were emailed on June 25, 2021 for fees not paid by the May 10, 2021 due date. And, holy smokes, there are almost 500 firms on the arrears list. Twenty‑eight are contract manufacturing organizations […]
Today, the Federal Register announced the 2022 MDUFA fees (here). As the FDA notes, “This notice establishes the fee rates for FY 2022, which apply from October 1, 2021 through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may […]
The Federal Register announced the BsUFA fees for FY 2022 today (here) and, for the second year in a row, the fees have decreased or, in the case of applications, stayed the same. Fee Category Rates for FY 2021 Rates for FY 2022 Percent Change Initial BPD $102,494 $57,184 -44.3 Annual BPD $102,494 $57,184 -44.3 […]
Outsourcing facilities are compounders registered with the FDA under Section 503B of the Federal Food Drug and Cosmetic Act. They undergo FDA inspections and must follow cGMPs as they relate to compounded prescription drug products that they are authorized to compound. Good news for the 503B facilities – their fees have not gone up much […]
