Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Can you please point me to guidance documents from the FDA and Health Canada to indicate that 
a new drug dossier (NDA in the USA, or NDS in Canada) need to include a Nitrosamines assessment

If the answer is yes, where would that assessment be included in the dossier?

If there is no document to require that assessment, would you still include one voluntarily?

Thank you for reading!

FDA Guidance is here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs

Health Canada:  https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities.html

The information will go in Module 3 in discussion of impurities.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 19-Apr-2021 14:36
From: Anonymous Member
Subject: Nitrosamines Assessment Report Needed in NDA or NDS?

This message was posted by a user wishing to remain anonymous

Hello,

Can you please point me to guidance documents from the FDA and Health Canada to indicate that
a new drug dossier (NDA in the USA, or NDS in Canada) need to include a Nitrosamines assessment

If the answer is yes, where would that assessment be included in the dossier?

If there is no document to require that assessment, would you still include one voluntarily?

Thank you for reading!

You may want to review the attached FDA webinar slides from 2020 and more recent guideline from Feb 2021.
Chris

------------------------------
Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com
------------------------------

Original Message:
Sent: 19-Apr-2021 14:36
From: Anonymous Member
Subject: Nitrosamines Assessment Report Needed in NDA or NDS?

This message was posted by a user wishing to remain anonymous

Hello,

Can you please point me to guidance documents from the FDA and Health Canada to indicate that
a new drug dossier (NDA in the USA, or NDS in Canada) need to include a Nitrosamines assessment

If the answer is yes, where would that assessment be included in the dossier?

If there is no document to require that assessment, would you still include one voluntarily?

Thank you for reading!