Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and ...
In light of this, the OIG examined the FDA's decision-making process in a sample of 24 accelerated ... In addition, some meetings with Biogen about aducanumab appeared to be missing from the ...
today announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the APOLLO post-marketing confirmatory trial for bitopertin in EPP.
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