User Fees

Rough roadway

Update on Meeting CDER User Fee Goals During Pandemic – Not Too Bad!

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 […]

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How did that happen?

So Now We Know Why the OMUFA User Fee Notice Was Withdrawn

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 […]

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Confused businesswoman looking at camera

Whoops – Somebody Goofed!

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 […]

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Meeting and Application Goal Dates – Questions and Answers of Impact of COVID-19 Work

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) […]

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