Health Advisory: Pharmacogenomic Data Submission in New Drug Applications, Investigative New Drug Applications, and Biologics License Applications
4/21/2005
On March 22, 2005, the Food and Drug Administration (FDA) issued a final Guidance containing recommendations for the submission of pharmacogenomic data in applications for new drugs and biologics. Although nonbinding, the Guidance is nonetheless significant in that it marks the FDA's first step toward integrating the rapidly evolving science of pharmacogenomics into existing regulatory processes.
To learn further information including why the FDA issued the Guidance click here.
