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  • 1.  ANDA submission - Incomplete stability data

    This message was posted by a user wishing to remain anonymous
    Posted 3 days ago
    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!


  • 2.  RE: ANDA submission - Incomplete stability data

    Posted 2 days ago
    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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