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Guidance Documents/Guidance-Document/Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601

Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

March 1, 2005

June 15, 2019

Center for Drug Evaluation and Research

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