The FDA can issue a CRL for both original applications or supplements.
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Aziz Alam
Sr. Director, Regulatory Affairs
Aurora IL
United States
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Original Message:
Sent: 08-Nov-2021 16:13
From: Anonymous Member
Subject: CRL
This message was posted by a user wishing to remain anonymous
Are CRLs(FDA complete response letter) apply only to original application or to supplements as well ? any guidance document would help - Thank You!