Government shutdown risks hampering FDA approvals, groups say in letter
With the agency already functioning at a reduced capacity due to the more than month-long impasse, 52 organizations say it risks keeping new therapies out of patients' hands.
Gossamer Bio goes public despite government shutdown halting most SEC operations
It was reported earlier this week in The Wall Street Journal that, while an IPO without the SEC signing off is allowed with a certain workaround, it is carries legal and regulatory risks.
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FDA hones activities amid shutdown, but impact on drugmakers appears limited so far
A regulatory consultant said his clients had not experienced any significant disruption, and the agency has been responsive to inquiries.