Harvard Catalyst Profiles

Contact, publication, and social network information about Harvard faculty and fellows.

Aaron Seth Kesselheim, M.D.

Co-Author

This page shows the publications co-authored by Aaron Kesselheim and Jonathan Darrow.
Connection Strength

17.504
  1. FDA Regulation and Approval of Medical Devices: 1976-2020. JAMA. 2021 08 03; 326(5):420-432.
    View in: PubMed
    Score: 0.986
  2. Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs. BMJ. 2020 06 23; 369:m2236.
    View in: PubMed
    Score: 0.913
  3. Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities. Lancet Infect Dis. 2020 07; 20(7):e159-e164.
    View in: PubMed
    Score: 0.909
  4. Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working? Open Forum Infect Dis. 2020 Jan; 7(1):ofaa001.
    View in: PubMed
    Score: 0.887
  5. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 01 14; 323(2):164-176.
    View in: PubMed
    Score: 0.885
  6. The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents. Appl Health Econ Health Policy. 2019 02; 17(1):47-54.
    View in: PubMed
    Score: 0.829
  7. The FDA Breakthrough-Drug Designation - Four Years of Experience. N Engl J Med. 2018 04 12; 378(15):1444-1453.
    View in: PubMed
    Score: 0.784
  8. The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health. N Engl J Med. 2018 Feb 01; 378(5):412-414.
    View in: PubMed
    Score: 0.767
  9. Will inter partes review speed US generic drug entry? Nat Biotechnol. 2017 12 08; 35(12):1139-1141.
    View in: PubMed
    Score: 0.765
  10. Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI. N Engl J Med. 2017 12 07; 377(23):2278-2286.
    View in: PubMed
    Score: 0.765
  11. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. 2015 Sep 23; 351:h4633.
    View in: PubMed
    Score: 0.657
  12. Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med. 2015 Jan 15; 372(3):279-86.
    View in: PubMed
    Score: 0.626
  13. A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges? Food Drug Law J. 2015; 70(2):243-58, i.
    View in: PubMed
    Score: 0.624
  14. Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era? Yale J Health Policy Law Ethics. 2015; 15(2):293-347.
    View in: PubMed
    Score: 0.624
  15. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes. Clin Pharmacol Ther. 2015 Jan; 97(1):29-36.
    View in: PubMed
    Score: 0.621
  16. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 07 03; 371(1):89-90.
    View in: PubMed
    Score: 0.603
  17. Drug development and FDA approval, 1938-2013. N Engl J Med. 2014 Jun 26; 370(26):e39.
    View in: PubMed
    Score: 0.602
  18. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 Mar 27; 370(13):1252-8.
    View in: PubMed
    Score: 0.592
  19. Discovery and Development of Pregabalin (Lyrica): The Role of Public Funding. Neurology. 2021 Sep 07.
    View in: PubMed
    Score: 0.248
  20. Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling. JAMA Intern Med. 2021 Jul 01; 181(7):897-898.
    View in: PubMed
    Score: 0.245
  21. Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed. Clin Pharmacol Ther. 2021 10; 110(4):1018-1024.
    View in: PubMed
    Score: 0.245
  22. An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19. Health Aff (Millwood). 2021 01; 40(1):25-32.
    View in: PubMed
    Score: 0.235
  23. Drug Shortages and the Defense Production Act. Am J Public Health. 2020 10; 110(10):1504-1505.
    View in: PubMed
    Score: 0.233
  24. Origins and Ownership of Remdesivir: Implications for Pricing. J Law Med Ethics. 2020 09; 48(3):613-618.
    View in: PubMed
    Score: 0.231
  25. Comparing Onset of Biosimilar Versus Generic Competition in the United States. Clin Pharmacol Ther. 2020 12; 108(6):1308-1314.
    View in: PubMed
    Score: 0.231
  26. Understanding when real world data can be used to replicate a clinical trial: A cross-sectional study of medications approved in 2011. Pharmacoepidemiol Drug Saf. 2020 10; 29(10):1273-1278.
    View in: PubMed
    Score: 0.230
  27. Approximating Future Generic Entry for New Drugs. J Law Med Ethics. 2019 03; 47(1):177-182.
    View in: PubMed
    Score: 0.208
  28. An export-only exception to pharmaceutical patents in Europe: should the United States follow suit? Nat Biotechnol. 2019 01 03; 37(1):21-22.
    View in: PubMed
    Score: 0.206
  29. The US Biosimilar Market: Stunted Growth and Possible Reforms. Clin Pharmacol Ther. 2019 01; 105(1):92-100.
    View in: PubMed
    Score: 0.206
  30. Patent term restoration for top-selling drugs in the United States. Drug Discov Today. 2019 01; 24(1):20-25.
    View in: PubMed
    Score: 0.200
  31. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 12; 21(12):1382-1389.
    View in: PubMed
    Score: 0.198
  32. Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines. Health Aff (Millwood). 2018 05; 37(5):724-731.
    View in: PubMed
    Score: 0.197
  33. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines. J Clin Oncol. 2018 06 20; 36(18):1805-1812.
    View in: PubMed
    Score: 0.196
  34. Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship. Chest. 2018 01; 153(1):9-11.
    View in: PubMed
    Score: 0.192
  35. The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016. JAMA. 2017 12 05; 318(21):2137-2138.
    View in: PubMed
    Score: 0.191
  36. Expanded access to investigational drugs. N Engl J Med. 2015 04 09; 372(15):1473-4.
    View in: PubMed
    Score: 0.159
  37. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff (Millwood). 2014 Oct; 33(10):1770-8.
    View in: PubMed
    Score: 0.153
  38. The timing of 30-month stay expirations and generic entry: A cohort study of first generics, 2013-2020. Clin Transl Sci. 2021 Sep; 14(5):1917-1923.
    View in: PubMed
    Score: 0.061
Connection Strength
The connection strength for co-authors is the sum of the scores for each of their shared publications.

Publication scores are based on many factors, including how long ago they were written and whether the person is a first or senior author.
Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.