Industry Groups Seek Clarity From FDA On Exception Handling Under DSCSA
As supply chain partners drill down into implementing the last phase of Drug Supply Chain Security Act serialization, they ask FDA for more clarity, and some relief, on exception handling for products with no serial numbers after full track-and-trace goes into effect.
You may also be interested in...
US FDA Commissioner Scott Gottlieb says Congress intended to preempt all state licensure laws that were not identical to federal laws for licensing wholesalers and third-party logistics providers under the Drug Supply Chain Security Act.
US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.
While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.