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

Issue Date: March 1, 2005
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

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

This attachment to the guidance Pharmacogenomic Data Submissions is intended to illustrate when it would be appropriate to submit a voluntary (VGDS) genomic data submission versus a pharmacogenomic data submission required under 21 CFR 312, 314, or 601 (RGDS). Please refer to the complete guidance, or contact the relevant center if you have any questions. Examples for various topic areas are provided using the following format:

Download the Guidance Document