Jul/Aug 2022 CPD supplement - FDA meetings: how to hold a successful meeting across the drug development lifecycle


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To support its mission of protecting and advancing public health, the US FDA has established formal mechanisms to engage with sponsors and applicants. Meetings with the Agency are a critical component of the review and approval process for prescription drugs, biologics and medical devices. Meaningful, timely and formal FDA advice helps to de-risk and accelerate a product’s development, review and approval process. This continuing professional development supplement discusses the available meeting options for products regulated by CDER and CBER, which should help the reader select the appropriate avenue to receive the Agency’s advice and develop a viable regulatory interactions strategy

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