Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

For Generic drugs (ANDA's) we are noticing a trend where OGD would send an Information request (IR) very close to the Target action date requesting a quick response and once we respond they extend the goal date to another 3 months even though the comments are minor. Also, the comments from reviewers tend to change with each Information request. Some of these comments could have been brought up early on but they don't. What has been your experience with these delays?

Thanks. 

You may not be alone. I just saw an article which talks about the same issue. 

https://www.lachmanconsultants.com/2023/08/the-curious-case-of-the-latecycle-amendment-under-gdufa-iii/

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Mehul Govani RAC
Regulatory Affairs Manager
Westbury NY
United States
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Original Message:
Sent: 29-Jun-2023 13:59
From: Anonymous Member
Subject: OGD delays in approvals

This message was posted by a user wishing to remain anonymous

Hi All,

For Generic drugs (ANDA's) we are noticing a trend where OGD would send an Information request (IR) very close to the Target action date requesting a quick response and once we respond they extend the goal date to another 3 months even though the comments are minor. Also, the comments from reviewers tend to change with each Information request. Some of these comments could have been brought up early on but they don't. What has been your experience with these delays?

Thanks.