Accelerated Appproval US FDA Labeling Guidance Calls Out Surrogate Endpoints Needing Additional Context

Accelerated Appproval: US FDA Labeling Guidance Calls Out Surrogate Endpoints Needing ‘Additional Context’

17:08 EST 23 Jan 2019 | SCRIP

For Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state that...

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