The DMF process does not necessarily "ease" the review. Rather, in such classic cases where DMFs are used -- as where the maker of the Active Pharmaceutical Ingredient (API) is different from the person submitting an NDA or ANDA, the DMF allows the API holder to keep its trade secret processes and other valuable information confidential by giving FDA access to the data -- which is needed for the application review, but not allowing the API customer to see it.
If the API customer wants information on the processes in such a situation, the API maker often will have a non-confidential dossier available for its customers. In addition, some API makers will also let their customers conduct audits of their operations, but using third-party experts who are bound by contract to not disclose any trade secret information observed in their audits, but allowing the customer to verify GMP compliance.
______________________________________________
Michael A. Swit
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit https://twitter.com/FDACounsel -------------------------------------------
Original Message:
Sent: 09-13-2012 13:11
From: Keya Bandyopadhyay
Subject: Drug Master File
Hi,
The DMF provides significant amount data for the drug. There is no regulatory requirement to file Drug Master File. . My question is:
Does the submission of DMF eases the NDA/ANDA review process?
I guess that at least examiner gets answers of few questions from the DMF, so the review process gets easier.
Thanks in advance.
Keya