REMS, ‘Breakthrough’ Meetings Get ‘Type B’ Tag In Revised FDA Guidance
This article was originally published in The Pink Sheet Daily
In other modifications, FDA tells sponsors seeking Type A meetings – the most urgent category – that data packages must accompany the request.
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Requests for meetings with FDA staff about products in development should include pertinent details about pediatric study plans, human factors engineering plans and combination product information; new guidance documents on formal meetings under PDUFA VI and communications with IND sponsors operationalize user fee program commitments and will promote earlier, more thorough engagement, agency says.
Pre-submission meetings can address questions of clinically meaningful endpoints and appropriate subgroups, avoiding negative regulatory outcomes, FDA analysis suggests.
CDER Manual of Policy and Procedures describes specific actions FDA review staff will take once a product has received “breakthrough therapy” designation, with an emphasis on more meetings, more frequently.