Hi Anon,
The lack of complete stability data in the ANDA is a Refuse-to-Receive item. The only option is to hold the ANDA submission until you have a minimum of 180 days CRT and ACC data. Please keep in mind that OGD is very strict about the 180 day timeline, if the samples weren't in the stability chamber for at least 180 days, the ANDA will be refused.
Please take a look at the Refuse to Receive Standards and RtR Q&A guidances for backup.
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Lisa Apolis, RAC
Apolis Regulatory Consulting
Georgia, USA
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Original Message:
Sent: 24-Jan-2023 02:26
From: Anonymous Member
Subject: ANDA submission - Incomplete stability data
This message was posted by a user wishing to remain anonymous
Dear RAPS community,
My RA department is preparing for and original ANDA submission, but we are facing a minor delay from the product development team to provide us with stability data (p.8.2, p.8.3).
From your experience, would FDA accept an original ANDA with commitments/comments in sections p.8.2 and p.8.3 to send the data as an amendment ASAP? (timeframe is 15-30 calendar days after the initial submission)
Thank you!