NIH Gene Therapy AE Reporting Proposal Adopts FDA Reporting Requirements
Executive Summary
NIH's proposed gene therapy adverse event reporting plan would harmonize reporting requirements between NIH and FDA by adopting FDA gene therapy AE reporting procedures.
You may also be interested in...
Gene Therapy Trials Could Be Halted If Public Disclosure Is Not Made - FDA
FDA's gene therapy disclosure proposal would permit the agency to impose a clinical hold on trials if a sponsor fails to submit a redacted version of information for public disclosure.
Gene Therapy Trials Could Be Halted If Public Disclosure Is Not Made - FDA
FDA's gene therapy disclosure proposal would permit the agency to impose a clinical hold on trials if a sponsor fails to submit a redacted version of information for public disclosure.
FDA and NIH Would Get Harmonized AE Reports Under BIO Gene Therapy Plan
FDA and NIH would receive harmonized adverse event reports from gene therapy trial sponsors under a Biotechnology Industry Organization proposal.