Literature DB >> 21121835

Shattuck lecture. Innovation, regulation, and the FDA.

Margaret A Hamburg1.   

Abstract

Mesh:

Year:  2010        PMID: 21121835     DOI: 10.1056/NEJMsa1007467

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


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  11 in total

1.  Registries, research, and regrets: is the FDA's post-marketing REMS process not adequately protecting patients?

Authors:  Norman J Kachuck
Journal:  Ther Adv Neurol Disord       Date:  2011-11       Impact factor: 6.570

2.  The evolution of eProtocols that enable reproducible clinical research and care methods.

Authors:  Denitza P Blagev; Eliotte L Hirshberg; Katherine Sward; B Taylor Thompson; Roy Brower; Jonathon Truwit; Duncan Hite; Jay Steingrub; James F Orme; Terry P Clemmer; Lindell K Weaver; Frank Thomas; Colin K Grissom; Dean Sorenson; Dean F Sittig; C Jane Wallace; Thomas D East; Homer R Warner; Alan H Morris
Journal:  J Clin Monit Comput       Date:  2012-04-11       Impact factor: 2.502

Review 3.  Unlicensed and off-label uses of medicines: definitions and clarification of terminology.

Authors:  Jeffrey K Aronson; Robin E Ferner
Journal:  Br J Clin Pharmacol       Date:  2017-09-26       Impact factor: 4.335

4.  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Harlan M Krumholz; Joseph S Ross
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272

5.  Preparedness of the CTSA's structural and scientific assets to support the mission of the National Center for Advancing Translational Sciences (NCATS).

Authors:  Harry Shamoon; David Center; Pamela Davis; Mendel Tuchman; Henry Ginsberg; Robert Califf; David Stephens; Thomas Mellman; Joseph Verbalis; Lee Nadler; Anantha Shekhar; Daniel Ford; Robert Rizza; Reza Shaker; Kathleen Brady; Barbara Murphy; Bruce Cronstein; Judith Hochman; Philip Greenland; Eric Orwoll; Lawrence Sinoway; Harry Greenberg; Rebecca Jackson; Barry Coller; Eric Topol; Lisa Guay-Woodford; Marschall Runge; Robert Clark; Don McClain; Harry Selker; Curtis Lowery; Steven Dubinett; Lars Berglund; Dan Cooper; Gary Firestein; S Clay Johnston; Julian Solway; James Heubi; Ronald Sokol; David Nelson; Larry Tobacman; Gary Rosenthal; Lauren Aaronson; Richard Barohn; Philip Kern; John Sullivan; Thomas Shanley; Bruce Blazar; Richard Larson; Garret FitzGerald; Steven Reis; Thomas Pearson; Thomas Buchanan; David McPherson; Allan Brasier; Robert Toto; Mary Disis; Marc Drezner; Gordon Bernard; John Clore; Bradley Evanoff; Julianne Imperato-McGinley; Robert Sherwin; Jill Pulley
Journal:  Clin Transl Sci       Date:  2012-03-27       Impact factor: 4.689

6.  Innovation under Regulatory Uncertainty: Evidence from Medical Technology.

Authors:  Ariel Dora Stern
Journal:  J Public Econ       Date:  2016-11-23

Review 7.  US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins.

Authors:  Marc Cohen; Walter P Jeske; Jose C Nicolau; Gilles Montalescot; Jawed Fareed
Journal:  J Thromb Thrombolysis       Date:  2012-04       Impact factor: 2.300

8.  Enhancing prescription drug innovation and adoption.

Authors:  G Caleb Alexander; Alec B O'Connor; Randall S Stafford
Journal:  Ann Intern Med       Date:  2011-06-21       Impact factor: 25.391

Review 9.  Getting it right: are regulation and registries for CT radiation dose in children the answer?

Authors:  Marilyn J Goske
Journal:  Pediatr Radiol       Date:  2011-08-17

10.  Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies.

Authors:  George A Neyarapally; Tarek A Hammad; Simone P Pinheiro; Solomon Iyasu
Journal:  BMJ Open       Date:  2012-09-25       Impact factor: 2.692

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