Dear all,
I have a question about field copy certification (1.3.2) in M1.
Several years ago, we submitted an ANDA including the below field copy certification. We submitted to FDA and local district office at the same time, so we said ".........................has notified the local district office located in ...............". Not sure if we still can use this template for new filing. And most important, do we need to notify the local district office prior to ANDA filing?
"XXX has notified the local district office located in Philadelphia, Pennsylvania, that it has filed an Abbreviated New Drug Application (ANDA) for XXXXXXXXX,5 mg and 10 mg with the Food and Drug Administration’s Office of Generic Drugs in electronic format and that the technical sections of the application can be accessed once the application is made available in the FDA Headquarters’ main server."
Appreciate any help!
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Jingyang Zhu
Downingtown PA
United States
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