By Daniela Drago and Danielle Helton Corwin2022-06-24T16:13:00
Source: Adobe stock
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.
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