Issue Date: March 1, 2005
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Good Clinical Practice (GCP)
Status: Final
Pharmacogenomic Data Submissions: Guidance for Industry
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).
Download the Guidance Document
