regulatory pathways

Regulatory pathways are formal processes that companies must follow to get approval for medical products, like drugs or devices, to ensure they are safe and effective. These pathways involve submitting detailed data to regulatory agencies (such as the FDA) for review. Different pathways may be used depending on the product's complexity and urgency, like accelerated programs for urgent medical needs. The goal is to balance thorough evaluation with timely access, ensuring that innovative treatments reach patients while maintaining high safety standards.