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How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.

Publication ,  Journal Article
Reed, SD; Califf, RM; Schulman, KA
Published in: Health Aff (Millwood)
2006

Changes in the economics of product development resulting from heightened safety regulations could have a sizable negative impact on drug and biotechnology companies' decisions about investing in innovation. We developed a model to compare the potential economic effects of pre- and postmarketing strategies to identify safety problems with new drugs. Although expanding Phase III clinical testing and postmarketing safety surveillance are not perfect substitutes, our findings suggest that even a large increase in funding for the latter will have a relatively small adverse impact on investment decisions by drug companies and venture capital firms, compared with the former.

Duke Scholars

Published In

Health Aff (Millwood)

DOI

EISSN

1544-5208

Publication Date

2006

Volume

25

Issue

5

Start / End Page

1309 / 1317

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Safety
  • Investments
  • Humans
  • Health Policy & Services
  • Government Regulation
  • Drug Industry
  • Diffusion of Innovation
  • Clinical Trials, Phase III as Topic
 

Citation

APA
Chicago
ICMJE
MLA
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Reed, S. D., Califf, R. M., & Schulman, K. A. (2006). How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health Aff (Millwood), 25(5), 1309–1317. https://doi.org/10.1377/hlthaff.25.5.1309
Reed, Shelby D., Robert M. Califf, and Kevin A. Schulman. “How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.Health Aff (Millwood) 25, no. 5 (2006): 1309–17. https://doi.org/10.1377/hlthaff.25.5.1309.
Reed SD, Califf RM, Schulman KA. How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health Aff (Millwood). 2006;25(5):1309–17.
Reed, Shelby D., et al. “How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.Health Aff (Millwood), vol. 25, no. 5, 2006, pp. 1309–17. Pubmed, doi:10.1377/hlthaff.25.5.1309.
Reed SD, Califf RM, Schulman KA. How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health Aff (Millwood). 2006;25(5):1309–1317.

Published In

Health Aff (Millwood)

DOI

EISSN

1544-5208

Publication Date

2006

Volume

25

Issue

5

Start / End Page

1309 / 1317

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Safety
  • Investments
  • Humans
  • Health Policy & Services
  • Government Regulation
  • Drug Industry
  • Diffusion of Innovation
  • Clinical Trials, Phase III as Topic