It has been a long time since I tried to get a waiver - ten years, maybe? I tried only once and the otherwise timely response was a request for more information that was so onerous that we went ahead and did the study without it, without any consequences. Of course, that was before the general concept of acceptance of foreign clinical data was adopted and before ex-US countries started to refuse signing 1572's. The language in the May FAQ makes it clear to me that it is better for FDA, and maybe their preference, that studies at foreign sites not be conducted under an IND. As questioned by others here on the forum, it is not clear to me why anyone would submit those sites to an IND.
Anyway, those are my thoughts.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States
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Original Message:
Sent: 09-Jun-2021 09:47
From: Bridgette Kunst
Subject: Review time for Form FDA 1572 waiver request - what is the general experience?
Hello,
Form FDA 1572 waiver requests have previously been a topic in this forum with good discussion on pros/cons for requesting a waiver. At this time, I am interested to hear members' experience on how long it has taken to receive FDA approval of a Form FDA 1572 waiver request. The timing of FDA review is a concern, in light of the FAQ draft guidance issued last month (Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs FAQs -May 2021) which states in Q43 that a site needs to wait to initiate the study at a site until the FDA 1572 waiver request has been granted. I have experience with a waiver that has been outstanding for 2 years!
Thank you in advance for any feedback!
Bridgette
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Bridgette Kunst MA, RAC
Managing Director
Bridge Regulatory Affairs, LLC
bkunst@bridgereg.com
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