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Posted On: 03/31/2019 7:39:17 PM
Post# of 154440
I was curious of the same. In the FDA link that describes the program it states that the FDA “Reviews the expanded access request and determines whether the expanded access request may proceed.”....along with the Investigational Review Board (IRB).
https://www.fda.gov/NewsEvents/PublicHealthFo...041768.htm
https://www.fda.gov/NewsEvents/PublicHealthFo...041768.htm
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