Module 1 2021

Implications for Non US Company

• If you do not have your place of business in the USA, you will need to appoint a US Agent • The US Agent can be an individual, firm or company physically located in the United States. The Agent is legally responsible for the IND • The Sponsor must inform FDA in writing of the name and address of the US Agent • The US Agent acts as the company representative and signs all the IND application forms (1571s) and is the contact point of FDA

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IND Review Process Summary

• FDA does not approve INDs • IND is “in effect” after 30 days (unless placed on clinical hold) − Based on calendar – no holidays allowed! − Clock begins when submission is logged into FDA Document Control Room − IRB approval required prior to clinical trial enrollment • Clinical hold may occur at any point in the life of the IND and may affect a single study or the entire IND • FDA Communication − May occur at any time during the course of the IND review − Clarifications are usually sought during the review process with the goal of avoiding clinical hold − Comments are advisory unless accompanied by a clinical hold order

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