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Posted On: 05/02/2025 8:40:05 PM
Post# of 154581
Someone was nice enough to share this with me.
https://www.drugs.com/clinical_trials/fda-gra...18133.html
Some of the things FTD does for us.
“More frequent written communications from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met;
Rolling Review, which means that a drug company can submit completed sections of its Biologics License Application (BLA) for review by the FDA, rather than waiting until every section is completed before the application can be reviewed.“
https://www.drugs.com/clinical_trials/fda-gra...18133.html
Some of the things FTD does for us.
“More frequent written communications from the FDA about such things as the design of the proposed clinical trials and use of biomarkers;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met;
Rolling Review, which means that a drug company can submit completed sections of its Biologics License Application (BLA) for review by the FDA, rather than waiting until every section is completed before the application can be reviewed.“
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