More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions
New FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.
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The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.
US regulators and GE have notified health-care providers that the company’s nurse bay monitoring stations could be attacked by malicious hackers to turn off critical alarms that are intended to alert caregivers when a patient is in a critical state.