You should write to the FDA Office of Generic Drugs to discuss with them.
There are a number of differences of ANDAs in eCTD format compared with NDAs/BLAs.
It would be good to assure you are using the correct checklists, bioequivalence tables, and are submitting the correct file formats.
There is an ANDA specialist in the FDA Office of Business Informatics who will respond to questions sent via email to
esubs@fda.hhs.gov.
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Antoinette Azevedo
President & CEO
e-SubmissionsSolutions.com
San Diego CA
United States
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Original Message:
Sent: 06-01-2011 09:11
From: Milad Khan
Subject: CTD vs e-CTD
Hello,
For a company in Bangladesh, can we submit an ANDA in CTD format in a CD instead of e-CTD?
Do you think I need a waiver for that?
Have anyone done this?
I would appreciate your experince in this regard.
Thank you.
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Milad Khan
Associate Director
Solco Healthacre US LLC
Costa Mesa CA
United States
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