This piece describes the impact of the federal government shutdown on FDA activities, noting that user fee-supported staff are continuing to work on pending drug application reviews. While the agency is not operating at optimal levels, the article includes Catalyst President Nancy Bradish Myers’ thoughts on the level of activity that is occurring.

For example, some of the company’s clients have been “pleased and a bit surprised with FDA’s level of engagement” since the shutdown began, Myers is quoted as saying. In addition, “project managers are communicating. Meeting preparation seems to be occurring…Decisions are being made. Even the labor-intensive Breakthrough Therapy designation consideration process seems to be on target time-wise.” The only questions note being answered are “broader policy questions” considered outside the scope of user fees, Myers says.

Shutdown Week Two: Could Sponsors Find A More Focused FDA?
The Pink Sheet

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