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  • The Orange Book blog team are a group of attorneys with McAndrews, Held and Malloy, which is a full-service IP firm representing both brands and generics in various aspects of IP law. This blog does not provide legal advice. If you are seeking legal advice, please contact the author directly.

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October 09, 2006

FDA Announces Improvements to ANDA Review Process

The FDA announced last Friday that it recently began using the Division File System (DFS) for reviewing and archiving Abbreviated New Drug Applications electronically.  According to the FDA's press release:

This system will now allow electronic archiving of ANDA documents for better tracking and search capabilities.  It will also enable reviews to become part of the official electronic record for a specific generic drug application.  DFS is also a mechanism for OGD and OND to have access to reviews completed in either Office, thus allowing full access to all available information on approved drug products.

FDA has been using DFS for New Drug Applications since October, 2000.

Posted by in FDA Announcements |

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