What does "fast track designation" enable for certain drugs?

Fast track designation is a mechanism used by the FDA that enables certain drugs, particularly those intended to treat serious conditions and fill an unmet medical need, to have facilitated development and an expedited review process. This designation aims to get important new therapies to patients more quickly.

When a drug receives fast track status, it benefits from more frequent communication with the FDA regarding the drug's development plan. This can include early meetings to discuss clinical trial design, and the possibility of submitting portions of the New Drug Application (NDA) for review before the complete application is submitted. Additionally, drugs with this designation may be eligible for priority review, allowing for an even faster assessment process once the application is submitted.

This approach is specifically designed to ensure that key treatment options are available as soon as possible for patients needing them, streamlining the regulatory pathway while still maintaining the necessary safety and efficacy standards.