Alan Minsk Quoted in FDANews Article on ICH Guidelines for Drugmakers

AGG Partner Alan G. Minsk is quoted in the May 15, 2012, issue of FDAnews Drug Industry Daily in an article titled “FDA Likely to Be Slow in Adopting ICH’s Final API Manufacturing Guideline” (subscription may be required to view), commenting on a guideline issued by the International Conference on Harmonisation (ICH). The guideline recommends that drugmakers use risk assessments to identify material and process characteristics that could alter the critical quality attributes of active pharmaceutical ingredients (APIs). While the FDA often adopts ICH guidelines, the process can be protracted.