Zdrowie i gospodarka · 18/10/2000

FDA Releases Guidance on Testing for Replication Competent Retrovirus in Gene Therapy Products

The Food and Drug Administration (FDA) has released a guidance document dated October 2000, providing supplemental guidance on testing for replication competent retrovirus in gene therapy products and follow-up monitoring of patients in clinical trials using retroviral vectors, finalizing a draft guidance document announced in 1999 and supplementing a 1998 guidance document on human somatic cell therapy and gene therapy.