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Nature Reviews. Drug Discovery
|
May 13, 2017
Combination products: modernizing the regulatory paradigm
Nina L Hunter, Rachel E Sherman
Health Affairs (Project Hope)
|
October 11, 2012
Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research
Joseph P Griffin, Bryant M Godfrey, Rachel E Sherman
The New England Journal of Medicine
|
November 15, 2013
Expediting drug development--the FDA's new "breakthrough therapy" designation
Rachel E Sherman, Jun Li, Stephanie Shapley, et al.
Nature Reviews. Drug Discovery
|
February 25, 2017
Accelerating development of scientific evidence for medical products within the existing US regulatory framework
Rachel E Sherman, Kathleen M Davies, Melissa A Robb, et al.
JAMA
|
January 23, 2014
Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012
Leonard V Sacks, Hala H Shamsuddin, Yuliya I Yasinskaya, et al.
JAMA
|
May 3, 2012
Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010
Robert M Califf, Deborah A Zarin, Judith M Kramer, et al.
Clinical Trials (London, England)
|
September 17, 2015
The Food and Drug Administration and pragmatic clinical trials of marketed medical products
Monique L Anderson, Joseph Griffin, Sara F Goldkind, et al.
American Heart Journal
|
July 29, 2014
Independent data monitoring committees: preparing a path for the future
Connie N Hess, Matthew T Roe, C Michael Gibson, et al.
Page
of 1
Search research articles
Search
Showing results (1-10 of 8) with videos related to
Sort By:
Page
of 1
Nature Reviews. Drug Discovery
|
May 13, 2017
Combination products: modernizing the regulatory paradigm
Nina L Hunter, Rachel E Sherman
Health Affairs (Project Hope)
|
October 11, 2012
Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research
Joseph P Griffin, Bryant M Godfrey, Rachel E Sherman
The New England Journal of Medicine
|
November 15, 2013
Expediting drug development--the FDA's new "breakthrough therapy" designation
Rachel E Sherman, Jun Li, Stephanie Shapley, et al.
Nature Reviews. Drug Discovery
|
February 25, 2017
Accelerating development of scientific evidence for medical products within the existing US regulatory framework
Rachel E Sherman, Kathleen M Davies, Melissa A Robb, et al.
JAMA
|
January 23, 2014
Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012
Leonard V Sacks, Hala H Shamsuddin, Yuliya I Yasinskaya, et al.
JAMA
|
May 3, 2012
Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010
Robert M Califf, Deborah A Zarin, Judith M Kramer, et al.
Clinical Trials (London, England)
|
September 17, 2015
The Food and Drug Administration and pragmatic clinical trials of marketed medical products
Monique L Anderson, Joseph Griffin, Sara F Goldkind, et al.
American Heart Journal
|
July 29, 2014
Independent data monitoring committees: preparing a path for the future
Connie N Hess, Matthew T Roe, C Michael Gibson, et al.
Page
of 1