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Postmarketing trials and pediatric device approvals.
Hwang TJ, Kesselheim AS, Bourgeois FT. Hwang TJ, et al. Pediatrics. 2014 May;133(5):e1197-202. doi: 10.1542/peds.2013-3348. Epub 2014 Apr 14. Pediatrics. 2014. PMID: 24733871 Free PMC article.
Life cycle of medical product rules issued by the US Food and Drug Administration.
Hwang TJ, Avorn J, Kesselheim AS. Hwang TJ, et al. J Health Polit Policy Law. 2014 Aug;39(4):751-80. doi: 10.1215/03616878-2743027. Epub 2014 May 19. J Health Polit Policy Law. 2014. PMID: 24842974
Target small firms for antibiotic innovation.
Hwang TJ, Carpenter D, Kesselheim AS. Hwang TJ, et al. Science. 2014 May 30;344(6187):967-9. doi: 10.1126/science.1251419. Science. 2014. PMID: 24876477 No abstract available.
Drug safety in the digital age.
Hwang TJ, Bourgeois FT, Seeger JD. Hwang TJ, et al. N Engl J Med. 2014 Jun 26;370(26):2460-2. doi: 10.1056/NEJMp1401767. N Engl J Med. 2014. PMID: 24963564 No abstract available.
Precision medicine and the FDA's draft guidance on laboratory-developed tests.
Hwang TJ, Lehmann LS, Kesselheim AS. Hwang TJ, et al. Nat Biotechnol. 2015 May;33(5):449-51. doi: 10.1038/nbt.3221. Nat Biotechnol. 2015. PMID: 25965745 No abstract available.
Accelerating innovation in rapid diagnostics and targeted antibacterials.
Hwang TJ, Powers JH, Carpenter D, Kesselheim AS. Hwang TJ, et al. Nat Biotechnol. 2015 Jun;33(6):589-90. doi: 10.1038/nbt.3251. Nat Biotechnol. 2015. PMID: 26057972 No abstract available.
Two decades of new drug development for central nervous system disorders.
Kesselheim AS, Hwang TJ, Franklin JM. Kesselheim AS, et al. Nat Rev Drug Discov. 2015 Dec;14(12):815-6. doi: 10.1038/nrd4793. Epub 2015 Nov 20. Nat Rev Drug Discov. 2015. PMID: 26585536 No abstract available.
Public referendum on drug prices in the US: will it bring relief?
Hwang TJ, Kesselheim AS. Hwang TJ, et al. BMJ. 2016 Oct 31;355:i5657. doi: 10.1136/bmj.i5657. BMJ. 2016. PMID: 27799143 No abstract available.
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