FDA confirmed CMC and device plans are Phase 3 ready, coinciding with strengthening of US and EU patent estates.
2 reports, 2 independent
Updated Thu 00:00
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What happened
FDA confirmed CMC and device plans are Phase 3 ready, coinciding with strengthening of US and EU patent estates.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.EPO granted a drug patent while regulatory submissions were made to US and EU agencies.1 source
FDA confirmed Phase 3 readiness and US/EU patent estates are being strengthened.1 source
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The entities involved
- FDA
-
European Patent Office
one of the two organs of the European Patent Organisation
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