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

User-fee supported employees continue to work on pending reviews, and the lack of distractions from other tasks may help sponsors as the shutdown continues.

Application reviews may actually be progressing more efficiently during the government shutdown than under normal conditions, an unexpected advantage for regulated industry as federal agencies deal with employee furloughs and a lack of budget authority.

FDA is by no means operating at an optimal level during what it calls the “lapse period,” as many of its programs continue using carry-over user fee revenue. Steven Grossman,...

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