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Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to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.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.