You need to think about what it would gain you at this time, other than a Press Release for your company. If it's too late to get any of the benefits, FDA probably doesn't want to invest time and resources in it. Does your drug qualify for Priority Review or a rolling submission? That may be a better approach to speed up the review.
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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
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Original Message:
Sent: 08-Nov-2022 10:13
From: Anonymous Member
Subject: BTD request rejected: too close to application filing
This message was posted by a user wishing to remain anonymous
Hello,
Wondering if anyone in the forum has experience with FDA rejecting a request for BTD (RFD) because the request was filed too closely to the time of NDA/BLA submission? If so, can you please provide information on the examples?
Thank you!