Fox Rothschild's Marc Wagner on why domestic manufacturing reduces drug shortage risk — and why FDA inspection efficiency is as important as supply chain resilience.
Fox Rothschild's Marc Wagner on why scaling drug production is so slow — overseas API sourcing, supplier qualification, and FDA site approvals that take years.
As established gains in personalized and targeted therapy have enabled increasingly precise approaches to disease, novel technologies are expanding what is possible while creating new challenges for drug developers.