Module 1 2021

WORKING WITH THE FDA

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FDA Project Manager

• Contact the Head Project Manager in therapeutic area / Division to determine Project Manager for your company/product • Main contact at FDA – important to establish an open communication and a good working relationship with your key contact at the Agency (email, telephone) • FDA Project Managers assigned for IND - by class of drug or based on project workload • Role: − Addresses questions/queries from sponsors − Logs submissions and distributes for review; coordinates formal FDA meetings; generates FDA official minutes − Handles Compassionate Use IND, Research IND

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