Below are the basic responsibilities of US Agent.
FDA communicates with foreign companies through US Agent. It is important that your US Agent should understand the importance of regulatory communication and promptly act when necessary.
All the regulatory communications are routed through US Agent, your US Agent should be capable of effectively handling FDA communications and transmitting the information received from FDA without any delay.
Controlled correspondences related to generic drugs must be submitted by US Agent, so your Agent should be familiar with controlled correspondence filing process.
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