Regulatory Open Forum

Hi,
I have a question for you, regulatory professionals on the following scenario. If an NDA has been withdrawn by the Marketing Authorization Holder, the FDA has acknolwdged that, but has not yet published the notification in the Federal Register, what are the MAH reporting responsability for the product in the US?
Thanks.
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Caterina Altana
Aggregate Reporting
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Caterina,

You would want to ensure if there are any commitments/post-market requirements under FDAMA of 1997 and such is reported as explained in the FR 2012 or you may refer to http://wp.me/P4xpOK-19f 

I hope you don't mind my comments for the following: 

At FDA, the CDER seems to use the terms (Applicant Holder or NDA Holder) and the CVM seems to use the term "Marketing Authorization Holder (MAH)."

In EU and other countries, they seem to use the term "Marketing Authorization Holder (MAH)."

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Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 05-29-2015 16:29
From: Caterina Altana
Subject: Reporting responsibility

Hi,
I have a question for you, regulatory professionals on the following scenario. If an NDA has been withdrawn by the Marketing Authorization Holder, the FDA has acknolwdged that, but has not yet published the notification in the Federal Register, what are the MAH reporting responsability for the product in the US?
Thanks.
-------------------------------------------
Caterina Altana
Aggregate Reporting
-------------------------------------------