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misiu143

12/17/20 8:31 AM

#134102 RE: Blue Man #134101

Hopefully they have some exclusions from this rule ..
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Blue Man

12/17/20 8:41 AM

#134106 RE: Blue Man #134101

I may be wrong but I think the whole paragraph reads the FDA will only approve a drug that was approved by another "mature" regulatory body (U.S. FDA or any other country) OR "any other mature and established NRA as identified by FDA" which I believe the Philippines believe they have an established NRA. So sounds like the Philippine FDA can approve a drug from their reviewing the study rather than wait on another FDA elsewhere to approve a drug. Instead of getting the short stick and not getting a supply of approved drugs in the world since the "home" countries will likely get the most supply, their FDA can approve first. I think they may enjoy a bit of autonomy and not relying on the U.S. or other countries.