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Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era?
Kesselheim AS, Darrow JJ. Kesselheim AS, et al. Yale J Health Policy Law Ethics. 2015 Summer;15(2):293-347. Yale J Health Policy Law Ethics. 2015. PMID: 26333236
Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities.
Darrow JJ, Najafzadeh M, Stefanini K, Kesselheim AS. Darrow JJ, et al. Lancet Infect Dis. 2020 Jul;20(7):e159-e164. doi: 10.1016/S1473-3099(20)30197-3. Epub 2020 Jun 2. Lancet Infect Dis. 2020. PMID: 32502431 Review.
Understanding when real world data can be used to replicate a clinical trial: A cross-sectional study of medications approved in 2011.
Fralick M, Bartsch E, Darrow JJ, Kesselheim AS. Fralick M, et al. Among authors: darrow jj. Pharmacoepidemiol Drug Saf. 2020 Aug 14. doi: 10.1002/pds.5086. Online ahead of print. Pharmacoepidemiol Drug Saf. 2020. PMID: 32798299
Drug Shortages and the Defense Production Act.
Raunig BL, Kesselheim AS, Darrow JJ. Raunig BL, et al. Among authors: darrow jj. Am J Public Health. 2020 Oct;110(10):1504-1505. doi: 10.2105/AJPH.2020.305862. Am J Public Health. 2020. PMID: 32903085 No abstract available.
Practical, legal, and ethical issues in expanded access to investigational drugs.
Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Darrow JJ, et al. N Engl J Med. 2015 Jan 15;372(3):279-86. doi: 10.1056/NEJMhle1409465. N Engl J Med. 2015. PMID: 25587952 No abstract available.
New FDA breakthrough-drug category--implications for patients.
Darrow JJ, Avorn J, Kesselheim AS. Darrow JJ, et al. N Engl J Med. 2014 Mar 27;370(13):1252-8. doi: 10.1056/NEJMhle1311493. N Engl J Med. 2014. PMID: 24670173 No abstract available.
Expanded access to investigational drugs.
Sarpatwari A, Darrow JJ, Kesselheim AS. Sarpatwari A, et al. N Engl J Med. 2015 Apr 9;372(15):1473-4. doi: 10.1056/NEJMc1501823. N Engl J Med. 2015. PMID: 25853762 No abstract available.
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