Oct 1, 2022 | Drugs, On Demand Webinar
Foreign entities who operate in US FDA-regulated industries must have an appointed FDA US agent before they can import products into the US. At a minimum these FDA US agents provide the most basic of required services. However, agents with relevant experience and knowledge can provide much more.
Sep 1, 2019 | Ask the Expert, EASeNews
By Victoria Pankovich Each month EAS experts answer one question sent in by readers of EASeNews. This month’s question, on considerations for a reliable US Agent, is answered by Victoria Pankovich, Regulatory Specialist, who assists EAS clients with US Agent...
May 1, 2017 | Issue of the Month
By Bryan Coleman, EAS Senior Director Pharmaceutical & Device Consulting Services, and Victoria Pankovich, EAS Regulatory Specialist The FDA’s regulatory requirement for foreign firms to have a U.S. Agent can be confusing, to say the least. There are very specific...