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Real-World Evidence - What Is It and What Can It Tell Us?
Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Sherman RE, et al. N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216. N Engl J Med. 2016. PMID: 27959688 No abstract available.
Transforming Evidence Generation to Support Health and Health Care Decisions.
Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, Coster TS, Cunningham FE, De Lew N, DeSalvo KB, Dymek C, Dzau VJ, Fleurence RL, Frank RG, Gaziano JM, Kaufmann P, Lauer M, Marks PW, McGinnis JM, Richards C, Selby JV, Shulkin DJ, Shuren J, Slavitt AM, Smith SR, Washington BV, White PJ, Woodcock J, Woodson J, Sherman RE. Califf RM, et al. Among authors: sherman re. N Engl J Med. 2016 Dec 15;375(24):2395-2400. doi: 10.1056/NEJMsb1610128. N Engl J Med. 2016. PMID: 27974039 Free article. No abstract available.
The FDA Sentinel Initiative - An Evolving National Resource.
Platt R, Brown JS, Robb M, McClellan M, Ball R, Nguyen MD, Sherman RE. Platt R, et al. Among authors: sherman re. N Engl J Med. 2018 Nov 29;379(22):2091-2093. doi: 10.1056/NEJMp1809643. N Engl J Med. 2018. PMID: 30485777 No abstract available.
Flexibility in the FDA approach to orphan drug development.
Hunter NL, Rao GR, Sherman RE. Hunter NL, et al. Among authors: sherman re. Nat Rev Drug Discov. 2017 Nov;16(11):737-738. doi: 10.1038/nrd.2017.151. Epub 2017 Sep 1. Nat Rev Drug Discov. 2017. PMID: 28860647 No abstract available.
Combination products: modernizing the regulatory paradigm.
Hunter NL, Sherman RE. Hunter NL, et al. Among authors: sherman re. Nat Rev Drug Discov. 2017 Aug;16(8):513-514. doi: 10.1038/nrd.2017.66. Epub 2017 May 12. Nat Rev Drug Discov. 2017. PMID: 28496147
51 results