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Posted On: 03/20/2024 4:04:18 PM
Post# of 148866
As it might relate...with regard to our Immune Modulation Protocol
WHEN can Observational Studies support a drugs effectiveness?...The FDA
explains in New 8 page Draft guidance.
The New Draft guidance is part of a suite of documents the FDA has released on Real World Evidence.
It builds off a 2018 framework in which the Agency promised more clarity on How Drug Sponsors could take DATA collected Outside of carefully controlled Clinical Trials... in order to support New Indications for Approved drugs or to satisfy Post-Approval Study requirements.
__Endpoint News 3/20/24 Zachary Brennan Sr. Editor
WHEN can Observational Studies support a drugs effectiveness?...The FDA
explains in New 8 page Draft guidance.
The New Draft guidance is part of a suite of documents the FDA has released on Real World Evidence.
It builds off a 2018 framework in which the Agency promised more clarity on How Drug Sponsors could take DATA collected Outside of carefully controlled Clinical Trials... in order to support New Indications for Approved drugs or to satisfy Post-Approval Study requirements.
__Endpoint News 3/20/24 Zachary Brennan Sr. Editor
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