A guide to drug discovery: Trends in development and approval times for new therapeutics in the United States

@article{Reichert2003AGT,
  title={A guide to drug discovery: Trends in development and approval times for new therapeutics in the United States},
  author={Janice M. Reichert},
  journal={Nature Reviews Drug Discovery},
  year={2003},
  volume={2},
  pages={695-702}
}
The process of clinical development and regulatory review of new therapeutics in the United States was significantly changed by a number of legislative acts passed in the 1980s and 1990s. These acts were designed to encourage the development of innovative products, especially for rare, serious or life-threatening diseases, and to ensure that patients had timely access to these treatments. To assess the effects of the various modifications to the process, the Tufts Center for the Study of Drug… CONTINUE READING

From This Paper

Figures, tables, results, connections, and topics extracted from this paper.
59 Extracted Citations
21 Extracted References
Similar Papers

Citing Papers

Publications influenced by this paper.
Showing 1-10 of 59 extracted citations

Referenced Papers

Publications referenced by this paper.
Showing 1-10 of 21 references

trends in US approvals 1982–2002

  • J. M. Reichert, Paquette, C. Therapeutic recombinant proteins
  • Curr. Opin. Mol. Ther. 5, 139–147
  • 2003

trends in development and approval in the US

  • Reichert, J. M. Therapeutic monoclonal antibodies
  • Curr. Opin. Mol. Ther. 4, 110–118
  • 2002

Fast track product designation under the Food and Drug Administration Modernization Act : the industry experience

  • C.-P. Milne, E. Bergman
  • Drug Inf . J .
  • 2001

The effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the development and approval of therapeutic medicines

  • J. M. Reichert, J. Chee, C. S. Kotzampaltiris
  • Drug Inf. J. 35,
  • 2001

The new drug approvals of 1999, 2000, and 2001: drug development trends a decade after passage of the user fee act

  • K. I. Kaitin, C. Cairns
  • Drug Inf. J. (in the press)
  • 2001

the industry experience

  • Milne, C.-P., Bergman, E. Fast track product designation under the Food, Drug Administration Modernization Act
  • Drug Inf. J. 35, 71–83
  • 2001

Similar Papers

Loading similar papers…