Fast Track Program

The Food and Drug Administration Modernization Act of 1997 instructed FDA to specifically outline policies and procedures for "fast-track" drug products. The act states that "a drug designated as a fast track product is intended for treatment of a serious or life-threatening condition and demonstrates the r Fast track program: c To expedite development and review of drugs/biologics intended to treat serious or life-threatening conditions and with potential to address unmet medical needs; designated by FDA

r Priority review: o Faster FDA review times based on significant improvements compared to marketed products r Rolling submissions: o Allows for incremental submission of reviewable modules of NDA/BLA to reduce overall FDA review time; designated by FDA

Fig. 7.12. Regulatory "Opportunities"

potential to address an unmet medical need." There is FDA guidance outlining both when a disease is considered serious or life-threatening and when a drug can be considered to potentially address an unmet medical need. Unmet medical need is defined by FDA as well (e.g., drug effects serious outcome not seen with alternatives, improved effects for serious outcomes, benefits patients not tolerating alternatives, similar benefits of alternatives but avoiding serious side effects of alternatives). Sponsors may apply for fast-track designation at any time during drug development by presenting data that the new drug meets the criteria for treatment of both a serious and life-threatening condition and unmet medical need. Obtaining fast-track designation affords the sponsor an opportunity to access several programs to facilitate drug development and approval. These programs include early and frequent meetings with FDA, use of surrogate end points documented to be predictive of clinical benefit, the potential for priority review, "rolling" submissions for approval (discussed below), and/or accelerated approval. The FDA may require follow-up studies as part of the approval under fast-track status to confirm specific clinical issues of safety or efficacy.

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