BIO Comments on FDA Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs

On Tuesday, December 13th, BIO submitted comments in response to a recent FDA discussion paper for stakeholders on distributed manufacturing (DM) and point-of-care (POC) manufacturing. In the comments submitted, BIO commended the FDA on its collaborative approach to addressing unique challenges related to advanced manufacturing and noted that discussion paper provides a timely mechanism to further the harmonization of terminology and concepts around DM and POC. Along with specific feedback on the questions raised by the Agency in the paper, BIO offered several high-level recommendations. For example, it would be beneficial if FDA more clearly conveyed the benefits offered by DM and POC manufacturing while acknowledging the relative risks associated with their introduction. Furthermore, it would be useful if the document recognized and addressed the limitations that manufacturers face in attempting to deploy these technologies in different regions and settings.