EOP2 meeting

Conventional Biologies In addition to the items listed in this section, CMC issues that could be addressed in EOP2 meetings for conventional biologies (e.g., nonrecombinant vaccines and blood products) include, but are not limited to... 

A pre-NDA meeting is typically held as the phase III clinical trials are concluding. The principal objective is to check how the issues identified at the EOP2 meeting have been resolved. At this meeting, the entire structure of the forthcoming... 

The best NDAs have a table of contents before the EOP2 meeting, and are built as the various component nonclinical and clinical study reports become available. Most companies do this both electronically and as paper hard copy. At present, FDA requires the submission of both, although PDUFA requires FDA to be able to accept just an electronic version by 2002. The structure is well described in the regulation, which the student is again urged to read. 

A further example relates to the pre-IND meeting. Some FDA divisions do not like them, and if reviewers attend, they have a tendency to provide less valuable information than they would for an EOP2 meeting or a pre-NDA meeting, the so-called entitled meetings . But, within the industry, there are a number of companies who have similar attitudes about the value of pre-IND meetings. The notable difference is that the FDA has to go to the pre-IND meeting if scheduled. The companies who see little value merely do not schedule them. 

The EOP2 meeting provides a firm with an opportunity to discuss their plans and protocols for phase 3, NDA and market. A CMC-specific EOP2 meeting is held principally as a CMC strategy discussion. It is the most critical IND meeting... 

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