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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry

Al's Comment:

 This is a guidance document from the FDA which talks about what proof is now needed to get a new drug approved.  It looks very favorable to the brain tumor community - there is a lot more flexibility than there used to be!  Good work by the FDA.


Posted on: 01/29/2020

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry 

 


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