Downing NS - Search Results

1

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

Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Downing NS, et al. JAMA. 2014 Jan 22-29;311(4):368-77. doi: 10.1001/jama.2013.282034. JAMA. 2014. PMID: 24449315 Free PMC article.

2

Regulatory review of novel therapeutics--comparison of three regulatory agencies.

Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Downing NS, et al. N Engl J Med. 2012 Jun 14;366(24):2284-93. doi: 10.1056/NEJMsa1200223. Epub 2012 May 16. N Engl J Med. 2012. PMID: 22591257 Free PMC article.

3

Innovation, risk, and patient empowerment: the FDA-mandated withdrawal of 23andMe's Personal Genome Service.

Downing NS, Ross JS. Downing NS, et al. JAMA. 2014 Feb 26;311(8):793-4. doi: 10.1001/jama.2014.148. JAMA. 2014. PMID: 24474248 No abstract available.

4

Descriptions and interpretations of the ACCORD-Lipid trial in the news and biomedical literature: a cross-sectional analysis.

Downing NS, Cheng T, Krumholz HM, Shah ND, Ross JS. Downing NS, et al. JAMA Intern Med. 2014 Jul;174(7):1176-82. doi: 10.1001/jamainternmed.2014.1371. JAMA Intern Med. 2014. PMID: 24796406 Free PMC article.

5

Trial evidence and approval of therapeutic agents--reply.

Downing NS, Ross JS. Downing NS, et al. JAMA. 2014 May;311(20):2129. doi: 10.1001/jama.2014.3420. JAMA. 2014. PMID: 24867021 No abstract available.

6

Withdrawal of Personal Genome Service--reply.

Downing NS, Ross JS. Downing NS, et al. JAMA. 2014 Jun 18;311(23):2441-2. doi: 10.1001/jama.2014.5584. JAMA. 2014. PMID: 24938574 No abstract available.

7

Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study.

Smithy JW, Downing NS, Ross JS. Smithy JW, et al. Among authors: downing ns. JAMA Intern Med. 2014 Sep;174(9):1518-20. doi: 10.1001/jamainternmed.2014.3438. JAMA Intern Med. 2014. PMID: 25070357 Free PMC article. No abstract available.

8

Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013.

Krumholz HM, Nuti SV, Downing NS, Normand SL, Wang Y. Krumholz HM, et al. Among authors: downing ns. JAMA. 2015 Jul 28;314(4):355-65. doi: 10.1001/jama.2015.8035. JAMA. 2015. PMID: 26219053 Free PMC article.

9

Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.

Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Downing NS, et al. Trials. 2016 Apr 14;17:199. doi: 10.1186/s13063-016-1322-4. Trials. 2016. PMID: 27079511 Free PMC article.

10

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.

Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Rathi VK, et al. Among authors: downing ns. Otolaryngol Head Neck Surg. 2017 Feb;156(2):285-288. doi: 10.1177/0194599816684094. Epub 2017 Jan 17. Otolaryngol Head Neck Surg. 2017. PMID: 28093943

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