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Post# of 828445
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exwannabe

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exwannabe

Re: hankmanhub post# 555489

Monday, 01/02/2023 2:56:56 PM

Monday, January 02, 2023 2:56:56 PM

Post# of 828445

Were not some board members posting that under an ORBIS submission, there could be a coordinated approval by the cooperating regulators?


Orbis is a program where the FDA runs a review and other parties may be able to join in.,

Once the staff review (possibly joint) completes then the individual RAs make their decisions. The FDA has been acting faster on actually approving after the review.
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