User Fees

27
Jul
FEES CHARGED - words on calculator.Money in hand and office supplies

503B Outsourcing Inspection Fees for 2024 Just Released

The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities (503B registered facilities)” that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The FD&C Act authorizes FDA to assess and […]

Read More
27
Jul
Woman worried about bills

BsUFA and MDUFA FY 2024 Fees Published! Good News for BsUFA Fees, Not So Much for MDUFA Fees

The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024.  BsUFA Fees  The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for […]

Read More
27
Jul
Fees

PDUFA User Fee Rates for FY 2024

The PDUFA user fees all rose, not much of a surprise!  However, we are now getting into some serious money to submit a new NDA.  These fees could (in some instances) deter smaller applicants from entertaining NDA submissions as they might price them right out of the market.  And if it is not the NDA […]

Read More
27
Jul
Stack of one hundred dollars notes on dollars background

New GDUFA Fees for FY 2024

On the Federal Register (FR) prepublication page today, the FDA outlined the new fee schedule for generic drugs under the GDUFA program for FY 2024.  Make sure you have a bottle of Maalox nearby before you read the rest of this blog as the increases, especially for the program fees, might cause you some agita.  Generic […]

Read More
24
Mar

FY 2023 OTC User Fees Announced

This morning, the FDA published the OTC User Fee rates for FY 2023 in a Federal Register notice (here); these rates cover fees for OTC manufacturing facilities (MFD), contract manufacturing organizations (CMO), and OTC monograph order requests (OMORs) for which there are tier 1 and tier 2 requests.  A comparison of the first three fiscal years is presented […]

Read More
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OTC Monograph User Fee (OMUFA) Draft Guidance Published Today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you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when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 […]

Read More
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 […]

Read More
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 […]

Read More
14
Sep

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 […]

Read More
1 2 4