Bot Chart, page-3346

Definitely! Fast track is amazing, and definitely adds value. Thanks for your post, so I was intrigued so did a bit of googling.

Here are some more incentives of being fast tracked:

More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approvalMore frequent written correspondence from FDA about such things as the design of the proposed clinical trialsAccelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit.

Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.

Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Thanks Bernsta!