The U.S. FDA this week issued a draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs. The 27-page draft guidance is part of the FDA’s effort to encourage the adoption of continuous manufacturing and covers quality considerations for solid oral small molecule drugs and builds on feedback from a public consultation launched in 2017. According to FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock, continuous manufacturing “transforms the traditional, step-wise manufacturing process into a single system that’s based on modern process monitoring and controls. Learn More