http://en.wikipedia.org/wiki/FDA_Fast_Track_Develo

http://en.wikipedia.org/wiki/FDA_Fast_Track_D...nt_Program

Any drug being developed as a treatment or preventative measure for a disease that does not have a current therapy is labelled as an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

• Showing superior effectiveness


• Avoiding serious side effects of an available treatment


• Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome


• Decreasing a clinically significant toxicity of an accepted treatment

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval


• More frequent written correspondence from FDA about such things as the design of the proposed clinical trials


• Eligibility for FDA Accelerated Approval , i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit


• 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, and


• Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious disease.