What activities does the IPRG engage in?
• Reviews and evaluates VXDSs. • Meets with sponsors upon request before or after submitting a VXDS. • Consults upon request with review staff on required submissions containing genomic data. • Integrates pharmacogenomics into the regulatory review process and helps develop future guidance and review standards. • Harmonizes review practices and quality review systems for genomic data submissions. • Coordinates among disciplines and organizations in FDA, in particular CBER, CDER, Office of Combination Products (OCP), CDRH and NCTR, to assure the efficient, accurate, and transparent review of genomic data. • Coordinates public discussions and agendas for advisory committee meetings with regard to “lessons learned” from Genomic Data Submission review • Defines key issues to advance the use of rational pharmacogenomic principles in drug development, in particular issues pertaining to the regulatory review process. • Facilitates FDA internal education regarding pharmacogenomic data, includi
• Reviews and evaluates VXDSs. • Meets with sponsors upon request before or after submitting a VXDS. • Consults upon request with review staff on required submissions containing genomic data. • Integrates pharmacogenomics into the regulatory review process and helps develop future guidance and review standards. • Harmonizes review practices and quality review systems for genomic data submissions. • Coordinates among disciplines and organizations in FDA, in particular CBER, CDER, Office of Combination Products (OCP), CDRH and NCTR, to assure the efficient, accurate, and transparent review of genomic data. • Coordinates public discussions and agendas for advisory committee meetings with regard to “lessons learned” from Genomic Data Submission review. • Defines key issues to advance the use of rational pharmacogenomic principles in drug development, in particular issues pertaining to the regulatory review process. • Facilitates FDA internal education regarding pharmacogenomic data, includ
