FDA releases paper on distributed and point-of-care drug manufacturing

The Food and Drug Administration Friday released for comment through Dec. 13 a discussion paper on certain novel drug manufacturing technologies with the potential to increase timely access to drugs. 

“Pharmaceutical manufacturers have generally produced drugs at large fixed-location facilities, but some are now developing smaller, mobile drug manufacturing processes that can be deployed to multiple locations, including at the point of care, such as at a hospital or clinic,” FDA said. “These novel distributed manufacturing (DM) and point-of-care (POC) manufacturing technologies have the potential to improve the reliability and robustness of the drug supply chain.”