Module 1 2021

FDA: General Principles -1

• FDA is very data driven • Pre-plan interaction(s) to increase efficiency. Be specific / clear in requests or issues – Advice from FDA is only as good as the background information provided • Work with FDA in partnership – Early discussions to guide the development program • Company drug experts – FDA’s extended knowledge (i.e., access to a lot of data on a large number of drugs) • FDA Terminology – advise, recommend, suggest, should = must • Document interactions with FDA to ensure understanding and for appropriate follow-up, as needed

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FDA: General Principles - 2

• Start discussions with FDA early in development program – Effective use of FDA meetings, e.g. Pre-IND, EOP 1 and EOP 2 – Use various FDA review process to obtain guidance • Regulatory advice normally given in a structured way, in a structured process and generally, within a definitive timeframe • FDA has a large number of opinion leaders; seek expert advice to

refine your program (particularly important at AdCom) • US is an important market – impact of global climate

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