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: 0.951
  2. Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs. BMJ. 2020 06 23; 369:m2236.
    View in: PubMed
    Score: 0.880
  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: 0.877
  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: 0.856
  5. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 01 14; 323(2):164-176.
    View in: PubMed
    Score: 0.854
  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: 0.800
  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: 0.756
  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: 0.740
  9. Will inter partes review speed US generic drug entry? Nat Biotechnol. 2017 12 08; 35(12):1139-1141.
    View in: PubMed
    Score: 0.738
  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: 0.738
  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: 0.633
  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: 0.604
  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: 0.602
  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: 0.602
  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: 0.599
  16. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 07 03; 371(1):89-90.
    View in: PubMed
    Score: 0.582
  17. Drug development and FDA approval, 1938-2013. N Engl J Med. 2014 Jun 26; 370(26):e39.
    View in: PubMed
    Score: 0.581
  18. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 Mar 27; 370(13):1252-8.
    View in: PubMed
    Score: 0.571
  19. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence. Drug Saf. 2022 Feb 19.
    View in: PubMed
    Score: 0.247
  20. Recent Orange and Purple Book legislation suggests a need to bridge drug and biologic patent regimes. Nat Biotechnol. 2022 Feb; 40(2):167-169.
    View in: PubMed
    Score: 0.246
  21. Discovery and Development of Pregabalin (Lyrica): The Role of Public Funding. Neurology. 2021 10 26; 97(17):e1653-e1660.
    View in: PubMed
    Score: 0.239
  22. Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling. JAMA Intern Med. 2021 07 01; 181(7):897-898.
    View in: PubMed
    Score: 0.236
  23. 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: 0.236
  24. 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: 0.226
  25. Drug Shortages and the Defense Production Act. Am J Public Health. 2020 10; 110(10):1504-1505.
    View in: PubMed
    Score: 0.224
  26. Origins and Ownership of Remdesivir: Implications for Pricing. J Law Med Ethics. 2020 09; 48(3):613-618.
    View in: PubMed
    Score: 0.223
  27. Comparing Onset of Biosimilar Versus Generic Competition in the United States. Clin Pharmacol Ther. 2020 12; 108(6):1308-1314.
    View in: PubMed
    Score: 0.222
  28. 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: 0.222
  29. Approximating Future Generic Entry for New Drugs. J Law Med Ethics. 2019 03; 47(1):177-182.
    View in: PubMed
    Score: 0.201
  30. 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: 0.199
  31. The US Biosimilar Market: Stunted Growth and Possible Reforms. Clin Pharmacol Ther. 2019 01; 105(1):92-100.
    View in: PubMed
    Score: 0.199
  32. Patent term restoration for top-selling drugs in the United States. Drug Discov Today. 2019 01; 24(1):20-25.
    View in: PubMed
    Score: 0.193
  33. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 12; 21(12):1382-1389.
    View in: PubMed
    Score: 0.191
  34. 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: 0.190
  35. 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: 0.189
  36. Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship. Chest. 2018 01; 153(1):9-11.
    View in: PubMed
    Score: 0.185
  37. 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: 0.184
  38. Expanded access to investigational drugs. N Engl J Med. 2015 04 09; 372(15):1473-4.
    View in: PubMed
    Score: 0.153
  39. 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: 0.148
  40. Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel. Clin Pharmacol Ther. 2022 Mar 16.
    View in: PubMed
    Score: 0.062
  41. Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. J Gen Intern Med. 2022 Feb 09.
    View in: PubMed
    Score: 0.062
  42. The timing of 30-month stay expirations and generic entry: A cohort study of first generics, 2013-2020. Clin Transl Sci. 2021 09; 14(5):1917-1923.
    View in: PubMed
    Score: 0.059
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.