United States:
FDA Seeks Comments On Best Communication Practices Between IND Sponsors And FDA
11 November 2014
Jones Day
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In the October 29, 2014, Federal Register, FDA announced the
establishment of a docket to receive suggestions, recommendations,
and comments from interested parties, including academic
institutions, regulated industry, and other interested
organizations on best practices for communication between FDA and
investigational new drug application ("IND") sponsors
during drug development. FDA says it intends to issue draft
guidance in the future on this topic. Comments due
December 29, 2014.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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