Friedman said FDA is considering release of stability guidance
This article was originally published in The Gold Sheet
Executive Summary
CDER's Friedman reported at the June 23 meeting that any type of stability guideline issued by FDA will be "small scale," designed to complement the ICH guideline on stability testing. Friedman noted that FDA withdrew its stability guidance when the ICH guidance was issued in 1997. Other guidances due out soon, reported Friedman, include a new guidance on process validation and a guidance on parametric releas