Monday, April 2, 2018

Endo Agrees to Extend Temporary Stay of FDA Litigation | BioSpace
10 hours ago - In the new draft guidance, FDA also announced that if a "bulk drug substance is a component of an FDA-approved drug," prior to authorizing bulk compounding using that substance, "FDA intends to conduct a threshold review" to determine both (1) whether "an attribute of the FDA-approveddrug product makes it medically ...

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