Live Webinar: How and When to Use a US Agent When Dealing with the FDA When: Friday August 20, 2021 - 01:00 PM Duration: 60 Minutes.
The US agent for a company is key connection a company has with the FDA. All companies are required to designate an authorized representative, also called a US agent, for communicating with FDA. The US agent is also the key contact for the US customs for any import and export related issues. For non-US companies, the US agent is generally a contractor or consultant who helps the client navigate US laws and prepare appropriate documentations for regulatory approvals and notifications. It is important to understand the role and responsibilities of the US agent for seamless operations in the US. Lack of US agent could add to the delays and even hold critical decisions from FDA regarding a company.
This webinar will discuss the roles and responsibilities of US agents for US-based and non-US companies. The regulatory definition of US agent for different kinds of manufacturers, and locations will be discussed.
Areas Covered in the Session:
FDA definition of a US agent and its scope
Practical considerations for different kinds of products: drugs, cosmetics, devices, cosmetics, supplements, etc
SOPs needed for US agent tasks
Dos and don’ts for US agents
Suggested policies for interactions between US agents and FDA
Best practices for replacing US agents