User Fees

01
Nov

OTC Monograph User Fee (OMUFA) Draft Guidance Published Today

For those of you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when information about facility fees for dosage-form manufacturers […]

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06
Oct

Most User Fees for FY 2023 Appear on Federal Register Pre-Publication Page Today – But a Glitch with GDUFA Fees?

The schedules for the 2023 Prescription Drug User Fees (PDUFA) (here), Biosimilar User Fees (BSUFA) (here), and Medical Device User Fees (MDUFA) (here) have been posted and are scheduled for final publication on October 7, 2022.  However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the […]

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03
Oct

The User Fee Reauthorization Passed – The President Signed the Bill Into Law – But Still No Word on Where That Leaves the Industry

While passage of the Continuing Resolution by Congress on September 30, 2022 and corresponding reauthorization of user fees for the different programmatic areas is a relief, the extremely late passage of the Bill leaves FDA and Industry in an awkward position in relation to one of the most important elements of the reauthorization-submission of applications […]

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14
Sep
Blizzard

Countdown to Pink Slips

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 […]

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27
Jul

Outsourcing Facility Fee Rates for Fiscal Year 2023 Announced!

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 […]

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27
Jul

New Animal and Generic Animal User Fee Rates for FY 2023 are Barked Out Today

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. […]

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13
Jul

Is It Time to Rethink User Fees?

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 […]

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14
Mar

OTC User Fee Rates Published Today

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 […]

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31
Oct

OGD Published GDUFA III Commitment Letter

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 […]

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