FDA to Revise 20-Year-Old ICH Reproductive Risks Guideline

The FDA published an ICH-developed revision to its industry guideline on the detection of reproductive risks in new drugs.

The draft guideline elaborates on trial designs and identifies circumstances where risk assessments can be made, based on preliminary studies. It also clarifies the qualification and use of alternative assays.

The last revisions to the international guideline were adopted by the FDA in 1994 and 1996. The new draft text of the S5 guideline was issued by the ICH in July, and European Medicines Agency began its adoption and harmonization process in late August.