Skip to main content
SpringerLink
Log in

Walking the drug regulatory tightrope

  • Feature
  • Published:

From Nature Biotechnology

View current issue Submit your manuscript

Regulatory agencies are being pulled in several directions at once, and drug developers must learn to adapt swiftly to a rapidly changing landscape.

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: Mean times for clinical and approval phases of biopharmaceuticals over the past 20 years 7.
Figure 2: Approvals of biopharmaceuticals reviewed under standard and priority ratings from 1994 to 20027.

References

  1. Bouchie, A. FDA restructures product review centers. Nat. Biotechnol. 20, 960 (2002).

    Article  CAS  Google Scholar 

  2. Biotechnology Industry Organization CEO and Investor Conference, New York, NY, February 26–27, 2003.

  3. Dove, A. Betting on biogenerics. Nat. Biotechnol. 19, 117–120 (2001).

    Article  Google Scholar 

  4. Dove, A. Promising drug is victim of bad business. Nat. Med. 8, 199 (2002).

    Article  Google Scholar 

  5. Improving Innovation in Medical Technology: Beyond 2002 (FDA, Rockland, MD, 2002).

  6. Walsh, G. Drug approval in Europe. Nat. Biotechnol. 17, 237–240 (1999).

    Article  CAS  Google Scholar 

  7. Kaitin, K.I. (ed.). Biopharmaceutical product approval times dropped 21% since 1980s (Tufts Center for the Study of Drug Development Impact Report, 5(2), Mar/Apr, 2003).

Download references

Author information

Authors and Affiliations

  1. freelance writer working, Philadelphia, PA

    Alan Dove

Authors
  1. Alan Dove
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Dove, A. Walking the drug regulatory tightrope. Nat Biotechnol 21, 495–498 (2003). https://doi.org/10.1038/nbt0503-495

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt0503-495

  • Springer Nature America, Inc.

Search

Navigation