Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I recently had to scramble to update the contact information on an ANDA currently with the FDA for review.  The prior regulatory contact moved on to a new role/company.  While I was able to file an administrative update without too much issue I would like to see if anyone has a recommended path to have some redundancy in place.    In my latest filing I included both the applicant responsible party as well as myself as "regulatory contacts" via the ECTD filing however responses to that submission still only go to the responsible party listed on the 356 form.   Is there a way to have the ANDA correspondence for a single filing go to more than a single individual?

I have seen companies use email address like "Regulatoryaffairs@company.com" in the cover letter but the certification portion of the 356h form should be the applicant's responsible official.

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Mehul Govani RAC
Regulatory Affairs Manager
Bellerose NY
United States
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Original Message:
Sent: 25-Aug-2022 11:30
From: Anonymous Member
Subject: ANDA Contact/Multiple Contacts

This message was posted by a user wishing to remain anonymous

I recently had to scramble to update the contact information on an ANDA currently with the FDA for review.  The prior regulatory contact moved on to a new role/company.  While I was able to file an administrative update without too much issue I would like to see if anyone has a recommended path to have some redundancy in place.    In my latest filing I included both the applicant responsible party as well as myself as "regulatory contacts" via the ECTD filing however responses to that submission still only go to the responsible party listed on the 356 form.   Is there a way to have the ANDA correspondence for a single filing go to more than a single individual?