Regulatory Open Forum

Hi,

We have submitted ANDA to Agency in December 2019. GDUFA Goal date for this ANDA is October 2020. Review of this ANDA is going on & we received several DRL from the Agency & submitted our response. It seems we are now at the end stage of the review of ANDA. However, in one of the DRL, FDA stated that due to Travel restrictions currently they will not be able to inspect our facility & facility inspection is required before the application can be approved. In response to the above, we requested agency about alternative inspection plan i. e. Remote inspection/ mutual recognition considering SRA approval.

Do note that, Our facility has been approved by one of the stringent Regulatory Authority i. e UKMHRA & this is our first ANDA submission from this facility.

Can anyone have any idea on the above situation & Agency’s current expectations with the firms for which first ANDA submitted & no inspection was conducted by the FDA to date?

Thanks & Best regards

Rajib Kumar Baishnab
Senior Manager, Regulatory Affairs
The ACME Laboratories Ltd, Bangladesh
Cell: +8801990407587
Email: rbaishnab.qo@acmeglobal.com

This message was posted by a user wishing to remain anonymous

Not sure if it will, but today FDA published a guidance on this topic:

https://www.fda.gov/media/141312/download
Original Message:
Sent: 18-Aug-2020 01:07
From: Rajib Baishnab
Subject: PAI Inspection

Hi,

We have submitted ANDA to Agency in December 2019. GDUFA Goal date for this ANDA is October 2020. Review of this ANDA is going on & we received several DRL from the Agency & submitted our response. It seems we are now at the end stage of the review of ANDA. However, in one of the DRL, FDA stated that due to Travel restrictions currently they will not be able to inspect our facility & facility inspection is required before the application can be approved. In response to the above, we requested agency about alternative inspection plan i. e. Remote inspection/ mutual recognition considering SRA approval.

Do note that, Our facility has been approved by one of the stringent Regulatory Authority i. e UKMHRA & this is our first ANDA submission from this facility.

Can anyone have any idea on the above situation & Agency's current expectations with the firms for which first ANDA submitted & no inspection was conducted by the FDA to date?

Thanks & Best regards

Rajib Kumar Baishnab
Senior Manager, Regulatory Affairs
The ACME Laboratories Ltd, Bangladesh
Cell: +8801990407587
Email: rbaishnab.qo@acmeglobal.com