FDA’s Top Agenda Maker: Commissioner, Congress – Or The Courts?
This article was originally published in The Tan Sheet
Agency chief counsel says continued priority-setting through lawsuits eventually may affect public health, while professor says FDA discretion not to act is at stake in some cases.
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Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.
A court ruling allowing an advocacy group to move forward in its suit against FDA could pave the way for future litigation intended to force the agency to complete delayed regulations.