Dear Libby,
The IND becomes effective 30 days after the stated FDA receipt date unless the FDA sends notification otherwise. Annual reports should be submitted within 60 days of the anniversary date that the IND goes into effect.
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Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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Original Message:
Sent: 08-Apr-2022 08:50
From: Elizabeth Johnson
Subject: IND Effective Date for Annual report
Can anyone provide me guidance on when the effective date is for an IND annual report?
Is the effective date when the acknowledgement that the filing has been received, after the 30 days waiting period if no inquiries are made, or when FDA states you can proceed with study, if additional information is requested.?
Best Regards,
Elizabeth Johnson(Libby)
Project Manager,
Kiel Laboratories Inc.
5659 Southfield Drive
Flowery Branch, GA 30542
770-965-0006 ext: 207
ejohnson@kiellabs.com
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