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.
Five great reasons to become a TOPRA member:
Have you heard what you’re missing? Listen now to the RegRapPod podcast show, for free!