Harmonization Fail: ICH Guideline Doesn’t Simplify Safety Reporting, Firms Say
Crucially, the synchronization of landmark dates and reporting periods seems not to have been resolved by publication of the FDA/ICH document.
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An industry/regulator working group will flesh out the processes involved in the eight-step framework and identify data that can be used at each step, in both the pre-market and post-market stage.
Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to provide updates on benefit information along with safety signals to the regulatory authorities.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.