• Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications
  • Guidance Document Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample …
  • Revised Guidance Document: Acetaminophen Labelling Standard
  • Guidance Document - Biomarkers Related to Drug or Biotechnology Product Development: Context, …
  • Submitting risk management plans draft guidance document: Introduction