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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.
New regulatory paradigms for innovative drugs to treat pediatric diseases.
Hwang TJ, Bourgeois FT. Hwang TJ, et al. JAMA Pediatr. 2014 Oct;168(10):879-80. doi: 10.1001/jamapediatrics.2014.904. JAMA Pediatr. 2014. PMID: 25111315 Free PMC article. No abstract available.
Surgical applications of 3-dimensional printing and precision medicine.
Hwang TJ, Kiang C, Paul M. Hwang TJ, et al. JAMA Otolaryngol Head Neck Surg. 2015 Apr;141(4):305-6. doi: 10.1001/jamaoto.2015.44. JAMA Otolaryngol Head Neck Surg. 2015. PMID: 25695233 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Precision medicine and the FDA's draft guidance on laboratory-developed tests.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.
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