Fast Track Drug Development Programs

Title: Fast Track Drug Development Programs--Designation, Development, and Application Review

Date released: January 2006

Status: Final

Target audience: Industry sponsors (i.e., pharmaceutical and biotechnology companies)

Summary: New drugs or biological products for the prevention, diagnosis, or treatment of serious or life-threatening conditions with an unmet medical need may qualify for accelerated development and FDA review through the FDA's fast track programs. This guidance describes the regulations, policies, and procedures for the FDA's fast track programs.

Laws and regulations referenced:

• Section 112 of the FDA Modernization Act of 1997 (P.L. 105-115) (see Appendix 1 in this guidance) allows the FDA to 1) approve a marketing application for a product that has an effect on a clinical endpoint or a surrogate endpoint reasonably likely to predict clinical benefit and 2) review portions of a marketing application before receiving the complete application


• Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), which authorizes the FDA to facilitate the development and expedite the review of fast track products or drugs/biological products for serious and life-threatening conditions.


• 1988 interim rule "Procedures for Drugs Intended to Treat Life-Threatening and Severely Debilitating Illnesses" (21 CFR 312.80 through 312.88 (Subpart E)) describes procedures to facilitate the development of fast track drugs/biological products


• Center for Biologics Evaluation and Research SOPP 8405, which describes the procedures for the FDA's complete review and decision notification for fast-track new biological products


• Center for Drug Evaluation and Research MaPP 6020.3, which describes the FDA's priority review policy for fast-track new drugs

Rationale: To make new drugs/biological products for serious or life-threatening conditions available faster to the public. To do this, the FDA makes the drug development and review process easier for applicants of fast-track drugs.

Resulting recommendations:

A sponsor can apply for the fast track designation from the submission of the Investigational New Drug application (IND; this FDA approval is needed to begin clinical testing of a new drug/biological product) to before the submission of the New Drug Application (NDA) or Biological License Application (BLA) (these FDA approvals are needed to begin marketing of the new drug/biological product).

A sponsor must demonstrate that the new drug/biological product in development

1. is for a serious or life-threatening condition, i.e., a condition that causes a substantial impact on day-to-day functioning either by itself (e.g., cancer) or by its associated outcomes (e.g., depression)


2. is intended to treat a serious or life-threatening condition, i.e, has a preventive, diagnostic, or therapeutic effect on either the serious or life-threatening condition, a serious side effect of that condition, or a serious side effect(s) of currently available therapies for that condition [note: a nonserious condition that has rare/distant serious sequelae (e.g., duodenal ulcer) may qualify]


3. can address an unmet medical need for a serious or life-threatening condition by being the only available therapy or by improving upon either the safety or efficacy of currently available therapies

A sponsor must request a fast track designation and provide documentation for the serious or life-threatening condition and unmet medical needs, a basis for the new drug's potential to address the unmet medical needs, and the development plan for trials designed to evaluate the new drug's potential.

The FDA will respond within 60 days with a designation letter (approval) or nondesignation letter (disapproval, for which the sponsor can submit a subsequent request for fast track designation that the FDA will respond to within 60 days of receipt). During drug development, a sponsor must show the new drug/biological product's potential to continue receiving the fast track designation.

Once given a fast track designation,

1. The FDA will schedule additional meetings with a sponsor to aid the drug development program by discussing trial design, content of application submissions, etc.


2. The FDA will provide a sponsor with timely comments on the design of the trials proposed by the sponsor to show the fast track product's safety and efficacy, and end of phase 1/2 letters commenting on the adequacy of a sponsor's phase 2/3 development plans


3. The FDA will a) give priority review of NDA or BLA, b) allow a sponsor to submit portions of an NDA or BLA, and c) give accelerated approval (approval based on a not well-established surrogate endpoint that is reasonably likely to predict clinical benefit [e.g., improved exercise in refractory heart failure], although the FDA usually requires postmarketing studies for approvals based on surrogate endpoints or clinical endpoints other than survival/irreversible morbidity)

Impact: Sponsors are taking advantage of the fast track programs for their developing new drugs and biological products. Under the fast track programs, approved new drugs and biological products become available faster to the public. Unmet medical needs for the conditions addressed by these new drugs/biological products are being met faster.