FDA, Industry Collaborate On Genomics Guide

FDA, Industry Collaborate On Genomics Guide
Last month, the FDA issued its long-awaited draft guidelines for pharmacogenomic data submission. Companies large and small have been anxious to get their hands on these guidelines, for they are a critical starting point in the agency’s efforts to come up with the most appropriate requirements for pharmacogenomic data as part of a new drug application (NDA), a biologics license application (BLA) or even an investigational new drug application (IND).

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