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GUIDANCE DOCUMENT

Pharmacogenomic Data Submissions — Companion Guidance August 2007

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2007-D-0136
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to be used as a companion to the guidance Pharmacogenomic Data Submissions (March 2005). It reflects experience gained since the issuance of that guidance with voluntary genomic data submissions as well as with review by the FDA of numerous protocols and data submitted under investigational new drug (IND) applications, new drug applications (NDAs), and biologics license applications (BLAs). The recommendations are intended to facilitate scientific progress in the field of pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development. The FDA believes that the recommendations made in this companion guidance, together with the recommendations in the March 2005 guidance, will benefit sponsors considering the submission of either voluntary genomic data submissions or marketing submissions containing genomics data. As technology changes and more experience is gained, these recommendations may be updated.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2007-D-0136.