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Precision medicine and the FDA's draft guidance on laboratory-developed tests.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.
Safety and availability of clofazimine in the treatment of multidrug and extensively drug-resistant tuberculosis: analysis of published guidance and meta-analysis of cohort studies.
Hwang TJ, Dotsenko S, Jafarov A, Weyer K, Falzon D, Lunte K, Nunn P, Jaramillo E, Keshavjee S, Wares DF. Hwang TJ, et al. BMJ Open. 2014 Jan 2;4(1):e004143. doi: 10.1136/bmjopen-2013-004143. BMJ Open. 2014. PMID: 24384902 Free PMC article. Review.
Assessment of US pathway for approving medical devices for rare conditions.
Hwang TJ, Carpenter D, Kesselheim AS. Hwang TJ, et al. BMJ. 2014 Jan 17;348:g217. doi: 10.1136/bmj.g217. BMJ. 2014. PMID: 24443478 Review. No abstract available.
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.
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