In this part 1 of a 2-part video interview on the impacts of a government shutdown on pharmaceutical manufacturing and development, Megha Sinha, CEO, Kamet Consulting Group, discusses the complex logistical challenges teams face during a resulting FDA shutdown. According to Sinha, "The fastest way these type of shutdowns can turn into supply risk is through inspection and response bottlenecks." So, for approvals really in progress, a short shutdown may be absorbed, but really the shutdown creates this backlog, and that's the effect you'll see after reopening. So, the fastest way these type of shutdowns can turn into supply risk is through inspection and response bottlenecks. First, in case of inspection, in a shutdown scenario, FDA staffing and travel can be constrained.