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.
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.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A regulatory consultant said his clients had not experienced any significant disruption, and the agency has been responsive to inquiries.