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GUIDANCE DOCUMENT

Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 March 2005

Final

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

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Pharmacogenomic Data Submissions Attachment: Examples of Required or Voluntary Submissions

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:

Scenario

Type of Submission

Rationale


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.