Accelerating development of scientific evidence for medical products within the existing US regulatory framework.
Publication
, Journal Article
Sherman, RE; Davies, KM; Robb, MA; Hunter, NL; Califf, RM
Published in: Nat Rev Drug Discov
May 2017
Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA regulations embody sufficient flexibility to accommodate the emerging tools and methods needed to achieve this goal.
Duke Scholars
Published In
Nat Rev Drug Discov
DOI
EISSN
1474-1784
Publication Date
May 2017
Volume
16
Issue
5
Start / End Page
297 / 298
Location
England
Related Subject Headings
- United States Food and Drug Administration
- United States
- Time Factors
- Pharmacology & Pharmacy
- Humans
- Drug and Narcotic Control
- Drug Design
- Clinical Trials as Topic
- 42 Health sciences
- 32 Biomedical and clinical sciences
Citation
APA
Chicago
ICMJE
MLA
NLM
Sherman, R. E., Davies, K. M., Robb, M. A., Hunter, N. L., & Califf, R. M. (2017). Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov, 16(5), 297–298. https://doi.org/10.1038/nrd.2017.25
Sherman, Rachel E., Kathleen M. Davies, Melissa A. Robb, Nina L. Hunter, and Robert M. Califf. “Accelerating development of scientific evidence for medical products within the existing US regulatory framework.” Nat Rev Drug Discov 16, no. 5 (May 2017): 297–98. https://doi.org/10.1038/nrd.2017.25.
Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov. 2017 May;16(5):297–8.
Sherman, Rachel E., et al. “Accelerating development of scientific evidence for medical products within the existing US regulatory framework.” Nat Rev Drug Discov, vol. 16, no. 5, May 2017, pp. 297–98. Pubmed, doi:10.1038/nrd.2017.25.
Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov. 2017 May;16(5):297–298.
Published In
Nat Rev Drug Discov
DOI
EISSN
1474-1784
Publication Date
May 2017
Volume
16
Issue
5
Start / End Page
297 / 298
Location
England
Related Subject Headings
- United States Food and Drug Administration
- United States
- Time Factors
- Pharmacology & Pharmacy
- Humans
- Drug and Narcotic Control
- Drug Design
- Clinical Trials as Topic
- 42 Health sciences
- 32 Biomedical and clinical sciences