Manufacturing & Analytical Characterization
Xiaoming Xu, PhD (he/him/his)
Division Director
US Food and Drug Administration
Silver Spring, Maryland
Thilak Mudalige, PhD (he/him/his)
RESEARCH CHEMIST
US Food and Drug Administration
Jefferson, Arkansas
The rise of continuous manufacturing (CM) in the pharmaceutical industry—especially for solid oral dosage forms—marks a significant change in drug production. Over the past decade, the adoption of CM has been driven by substantial reductions in operational costs and shorter regulatory approval timelines, paving the way for its application across a variety of drug products. In this presentation, we will provide an overview of the regulatory science program that supports the development and adoption of advanced manufacturing technologies. We will also discuss case studies that illustrate the current landscape and future opportunities in this area.