Harvard Catalyst Profiles

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Rachel E. Sherman, M.D.

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Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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PMC Citations indicate the number of times the publication was cited by articles in PubMed Central, and the Altmetric score represents citations in news articles and social media. (Note that publications are often cited in additional ways that are not shown here.) Fields are based on how the National Library of Medicine (NLM) classifies the publication's journal and might not represent the specific topic of the publication. Translation tags are based on the publication type and the MeSH terms NLM assigns to the publication. Some publications (especially newer ones and publications not in PubMed) might not yet be assigned Field or Translation tags.) Click a Field or Translation tag to filter the publications.
  1. Platt R, Brown JS, Robb M, McClellan M, Ball R, Nguyen MD, Sherman RE. The FDA Sentinel Initiative - An Evolving National Resource. N Engl J Med. 2018 Nov 29; 379(22):2091-2093. PMID: 30485777.
    Citations:    Fields:    Translation:Humans
  2. Hunter NL, Rao GR, Sherman RE. Flexibility in the FDA approach to orphan drug development. Nat Rev Drug Discov. 2017 11; 16(11):737-738. PMID: 28860647.
    Citations:    
  3. Hunter NL, Sherman RE. Combination products: modernizing the regulatory paradigm. Nat Rev Drug Discov. 2017 Aug; 16(8):513-514. PMID: 28496147.
    Citations:    
  4. 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. PMID: 28232726.
    Citations:    
  5. Rappel MJ, Hunter NL, Alexandrow AI, Hair KO, Sherman RE, Califf RM. Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration. Clin Transl Sci. 2017 05; 10(3):124-127. PMID: 28079301.
    Citations:    
  6. Califf RM, Sherman RE, Slavitt A. Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS. JAMA. 2016 12 20; 316(23):2485-2486. PMID: 27820637.
    Citations:    
  7. 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. Transforming Evidence Generation to Support Health and Health Care Decisions. N Engl J Med. 2016 Dec 15; 375(24):2395-2400. PMID: 27974039.
    Citations: 17     Fields:    Translation:Humans
  8. 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. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med. 2016 Dec 08; 375(23):2293-2297. PMID: 27959688.
    Citations:    
  9. Anderson ML, Griffin J, Goldkind SF, Zeitler EP, Wing L, Al-Khatib SM, Sherman RE. The Food and Drug Administration and pragmatic clinical trials of marketed medical products. Clin Trials. 2015 Oct; 12(5):511-9. PMID: 26374684.
    Citations:    
  10. Hess CN, Roe MT, Gibson CM, Temple RJ, Pencina MJ, Zarin DA, Anstrom KJ, Alexander JH, Sherman RE, Fiedorek FT, Mahaffey KW, Lee KL, Chow SC, Armstrong PW, Califf RM. Independent data monitoring committees: preparing a path for the future. Am Heart J. 2014 Aug; 168(2):135-41.e1. PMID: 25066551.
    Citations:    
  11. Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. JAMA. 2014 Jan 22-29; 311(4):378-84. PMID: 24449316.
    Citations:    
  12. Sherman RE, Li J, Shapley S, Robb M, Woodcock J. Expediting drug development--the FDA's new "breakthrough therapy" designation. N Engl J Med. 2013 Nov 14; 369(20):1877-80. PMID: 24224621.
    Citations:    
  13. Griffin JP, Godfrey BM, Sherman RE. Regulatory requirements of the Food and Drug Administration would preclude product claims based on observational research. Health Aff (Millwood). 2012 Oct; 31(10):2188-92. PMID: 23048095.
    Citations:    
  14. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2012 May 02; 307(17):1838-47. PMID: 22550198.
    Citations:    
  15. Robb MA, Racoosin JA, Sherman RE, Gross TP, Ball R, Reichman ME, Midthun K, Woodcock J. The US Food and Drug Administration's Sentinel Initiative: expanding the horizons of medical product safety. Pharmacoepidemiol Drug Saf. 2012 Jan; 21 Suppl 1:9-11. PMID: 22262587.
    Citations: 29     Fields:    Translation:Humans
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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.