Managing Primary IND Applications with the FDA - Pharmaceutical Business Review

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Published 11 April 2011 | By Celerion

During the compilation of the data, it is natural to encounter results which stimulate the reader to wonder how the FDA would interpret the results and what their ensuing actions might be. In order to remove unpleasant yet preventable surprises after the filing of the IND, the FDA encourages, but does not require, pre-IND meetings where key matters can be discussed.

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