Pharmacogenomic Data Submissions Guidance for Industry March 2005
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
This guidance is intended to facilitate scientific progress in the field of pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development. The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) on (1) when to submit pharmacogenomic data to the Agency during the drug or biological drug product2 development and review processes, (2) what format and content to provide for submissions, and (3) how and when the data will be used in regulatory decision making. Key information, including examples of when pharmacogenomic data submissions would be required and when voluntary genomic data submissions (VGDSs) would be welcome are provided in a separate companion document (Pharmacogenomic Data Submissions, Attachment: Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601).
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:
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-2003-D-0031.