Just wishing to clarify things for myself.So in the past companies that applied for accelerated approval ,would no longer progress the trials until such stage as they were given fast track approval or not,then if they received fast track approval they would be able to sell the drug,whilst they prepared a confirmatory trial.whilst applying each year for an extension to this confirmatory trial.
The recent changes now allow a company whilst applying for accelerated approval to begin confirmatory trial design and trial…yeah??
Thus potentially leading to a much faster complete FDA commercial drug approval ??
Just wishing to clarify things for myself.So in the past...
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