Skip to main content

Advertisement

SpringerLink
Log in

A decade of the Fast Track programme

  • From the Analyst's Couch
  • Published:

From Nature Reviews Drug Discovery

View current issue Sign up to alerts

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Figure 1: Use of Fast Track (FT) designation, introduced in 1998, has increased significantly since 2002.
Figure 2: Fast Track indications were more frequently terminated and less frequently approved than other indications.
Figure 3: Phase transition probabilities were high in early development.

References

  1. Rutchick, J. & Zeltner, B. FDA's Fast Track designation more help to investors than patients. The Plain Dealer (Cleveland, Ohio) (1 Dec 2007).

    Google Scholar 

  2. Cohen, F. J. The Fast Track Effect. Nature Rev. Drug Discov. 3, 293–294 (2004).

    Article  CAS  Google Scholar 

  3. Thaul, S. CRS Report for Congress: FDA Fast Track and Priority Review Programs. National Agricultural Law Center web site [online], (2008).

    Google Scholar 

  4. Reichert, J. M. Trends in development and approval times for new therapeutics in the United States. Nature Rev. Drug Discov. 2, 695–702 (2003).

    CAS  Google Scholar 

  5. Kola, I. & Landis, J. Can the pharmaceutical industry reduce attrition rates? Nature Rev. Drug Discov. 3, 711–715 (2004).

    Article  CAS  Google Scholar 

  6. Center for Drug Evaluation and Research (CDER). CDER Fast Track Products Approved Since 1998 through 3/30/2007. CDER web site [online], (2007).

  7. Stoller, M. K. Economic effects of insomnia. Clin. Ther. 16, 873–897 (1994).

    CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Janice M. Reichert and Stephanie L. Rochon are at the Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, Massachusetts 02111, USA.,

    Janice M. Reichert & Stephanie L. Rochon

  2. Department of Health Policy and Management, Bodi D. Zhang is at Harvard University, School of Public Health, Kresge 4th Floor, 677 Huntington Avenue, Boston, Massachusetts 02115, USA.,

    Bodi D. Zhang

Authors
  1. Janice M. Reichert
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Stephanie L. Rochon
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Bodi D. Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Janice M. Reichert.

Related links

Related links

FURTHER INFORMATION

CBER Fast Track Designation Request Performance Report

CDER Fast track designation (FY 1998-FY 2006)

CDER Response to Request for “Fast Track” Designation FY 2007

FDA Guidance for Industry. Fast Track Drug Development Programs - Designation, Development, and Application Review

US Food and Drug Administration. Fast Track, Accelerated Approval and Priority Review

Rights and permissions

Reprints and permissions

About this article

Cite this article

Reichert, J., Rochon, S. & Zhang, B. A decade of the Fast Track programme. Nat Rev Drug Discov 7, 885–886 (2008). https://doi.org/10.1038/nrd2733

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd2733

  • Springer Nature Limited

Search

Navigation