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 FDA announced the Generic Animal Drug User Fee Rates for FY 2022 in today’s Federal Register here. This will be a first in an avalanche of announcements of new User Fee rates for the coming FY. The rates for Generic Animal Drugs for FY 2022 are provided in the table below: Fee Category […]
A Federal Register notice published on March 26, 2021 announced the Over-the-Counter (OTC) Monograph User Fee rates for the Agency’s newest UFA, OMUFA, 2021. There are two types of user fees; one is for facilities of firms that manufacture and distribute OTC products (monograph drug facilities (MDFs)) and the other is for a subset of […]
As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites. Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work. However, the statistics are not as bad as one might think, all […]
The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal. In the current FR Notice, the […]
On December 28, 2020, we published a blog post on the OMUFA fee structure for new OTC reviews and facilities (here). Today, in the prepublication of the Federal Register (FR) here, the FDA abruptly withdrew the FR Notice. Looks like someone along the way goofed as the notice bluntly indicates that “[T]he Department of Health […]
Another UFA – sounds like the noise an animal cartoon character might make. It is, however, no laughing matter. “On March 27, 2020, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security Act, which authorizes FDA to assess and collect user […]
The FDA announced the FY 2021 biosimilar user fees this morning on its Federal Register pre-publication page (here). The new fees can be found in the table below. BSUFA FY 2021 User fees Fee Category Rates for FY 2021 Rates for FY 2020 Percent Change Initial BPD $102,494 $117,987 -13.2% Annual BPD $102,494 $117,987 -13.2% […]
Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication. PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below. We await the GDUFA fee announcement, which we should see in a day or […]
The FDA released a guidance to remain in effect until the COVID-19 public health emergency is resolved titled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers ( here). In this guidance, the Agency addresses many questions they have been asked about scheduling meetings, face-to-face (FTF) […]
