Digital Health


Hwang TJ, Bourgeois FT, Seeger JD. Drug safety in the digital age. N Engl J Med 2014; 370(26): 2460-2462. [Link] [Pubmed]



Davies BJ, Hwang TJ, Kesselheim AS. Ensuring access to injectable generic drugs: intravesical BCG for bladder cancer. N Engl J Med 2017; 376(5): 1401-3. [Link] [Pubmed]


Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS*, Darrow J. Efficacy, safety, and regulatory approval of FDA-designated breakthrough and nonbreakthrough cancer medicines. J Clin Oncol 2018; 36(18): 1805-1812. [Link] [Pubmed]


Hwang TJ, Gyawali B. Association between progression‐free survival and patients' quality of life in cancer clinical trials. Int J Cancer 2019; 144(7): 1746-1751. [Link] [Pubmed]


Hwang TJ, Vokinger KN, Sachs R. Evaluating new rules on transparency in cancer research and drug development. JAMA Oncology 2019: In Press. [Link] [Pubmed]


Hwang TJ, Kesselheim AS, Gyawali B. Affordability and price increases of new cancer drugs in clinical guidelines, 2007–2016. JNCI Cancer Spectrum 2018;2(2): pky016. [Link] [Pubmed]



Hwang TJ, Carpenter D, Kesselheim AS. Target small firms for antibiotic innovation. Science 2014; 344(6187): 967-969. [Link]


Hwang TJ, Carpenter D, Kesselheim AS. Reimbursement incentives for antibiotics. Sci Transl Med 2015; 7(276): 276fs9. [Link]


Hwang TJ, Powers JH, Carpenter D, Kesselheim AS. Accelerating innovation in rapid diagnostics and targeted antibacterials. Nature Biotech 2015; 33(6): 589-590. [Link] [Pubmed]


Hwang TJ, Gibbs KA, Podolsky SH, Linder JA. Antimicrobial stewardship and public knowledge of antibiotics in the U.S., 1990-2012. Lancet Infect Dis 2015; 15(9): 1000-1001. [Link] [Pubmed]


Hwang TJ, Kesselheim AS. Leveraging novel and existing pathways to approve new therapeutics to treat serious drug-resistant infections. Am J Law Med 2016; 42(2): 429-450. [Link] [Pubmed]


Hwang TJ, Hooper DC. Association between fluoroquinolone resistance and resistance to other antimicrobial agents among E. coli urinary isolates in the outpatient setting: A national cross-sectional study. J Antimicrob Chemother 2014; 69(6): 1720-1722. [Pubmed]



Bourgeois FT, Hwang TJ. The Pediatric Research Equity Act moves into adolescence. JAMA 2017; 317(3): 259-260. [Link]


Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT. Completion and reporting of mandatory pediatric postmarketing studies under the Pediatric Research Equity Act. JAMA Pediatrics 2018: In Press. [Link] [Pubmed]


Hwang TJ, Tomasi PA, Bourgeois FT. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: a cohort study. PLOS Med 2018; 15(3): e1002520. [Link] [Pubmed]


Hwang TJ, Tomasi PA, Saint-Raymond A, Bourgeois FT. Availability of paediatric information in European Medicines Agency approvals. Lancet Child Adolesc Health 2018; 2(5): e9. [Link] [Pubmed]


Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS. Impact of the priority review voucher program on drug development for rare pediatric diseases. Health Affairs 2019; 38(2): 313-319. [Link] [Pubmed]


Bourgeois FT, Hwang TJ. Improving the study of new medicines for children with rare diseases. JAMA Pediatrics 2018; 172(1): 7-9. [Link] [Pubmed]


Hwang TJ, Bourgeois FT. New regulatory paradigms for innovative drugs to treat pediatric diseases. JAMA Pediatrics 2014; 168(10): 879-880. [Link] [Pubmed]

Medical Devices


Hwang TJ, Sokolov E, Franklin JM, Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ 2016; 353: i3323. [Link] [Pubmed]


Hwang TJ, Lehmann LS, Kesselheim AS. Precision medicine and the FDA's draft guidance on laboratory-developed tests. Nature Biotech 2015; 33(5): 449-451. [Link] [Pubmed]


Hwang TJ, Ciolino JB. Retinal implants and Medicare reimbursement policies for breakthrough treatments in ophthalmology. JAMA Ophthalmol 2015; 133(4): 373-374. [Link] [Pubmed]


Hwang TJ, Kiang CJ, Paul M. Surgical applications of three-dimensional printing and precision medicine. JAMA Otolaryngol Head Neck Surg 2015; 141(4): 305-306. [Link] [Pubmed]


Hwang TJ, Carpenter D, Kesselheim AS. Assessment of US pathway for approving medical devices for rare conditions. BMJ 2014; 348: g217. [Link] [Pubmed]


Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics 2014; 133(5): e1197-1202. [Link] [Pubmed]


Kesselheim AS, Hwang TJ. Breakthrough medical devices and the 21st Century Cures Act. Ann Intern Med 2016; 164(7): 500-502. [Link] [Pubmed]


Hwang J, Hwang TJ, Ciolino JB. Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012. BMJ Open 2015; 5(6): e007987. [Link] [Pubmed]

Innovation & Regulation


Hwang TJ, Darrow J, Kesselheim AS. The FDA's expedited programs and clinical development times for novel therapeutics, 2012-2016. JAMA 2017; 318(21): 2137-2138. [Link] [Pubmed]


Hwang TJ, Kesselheim AS, Sarpatwari A. Value-based pricing and state reform of prescription drug costs. JAMA 2017; 318(7): 609-610. [Pubmed] [Link]


Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS. Analysis of proposed Medicare Part B to Part D shift on total spending and patient cost-sharing for prescription drugs. JAMA Intern Med 2019: In Press. [Link] [Pubmed]


Hwang TJ, Franklin JM, Kesselheim AS. Effect of US Food and Drug Administration's cardiovascular safety guidance on diabetes drug development. Clin Pharmacol Ther 2017; 102(2): 290-296. [Link] [Pubmed]


Hwang TJ, Kesselheim AS. Challenges in the development of novel cardiovascular therapies. Clin Pharmacol Ther 2017; 102(2): 194-196. [Link] [Pubmed]


Jain N, Hwang TJ, Franklin JM, Kesselheim AS. Association of the priority review voucher with neglected tropical disease drug and vaccine development. JAMA 2017; 318(4): 388-389. [Link] [Pubmed]


Hwang TJ, Carpenter D, Lauffenburger JL, Wang B, Franklin JM, Kesselheim AS. Failure of investigational drugs in late-stage clinical development and publication of trial results. JAMA Intern Med 2016; 176(12): 1826-33. [Link] [Pubmed]


Hwang TJ, LaMattina JL. Measuring the value of new medications and implications for Medicare's proposed Part B drug payment model. JAMA Oncol 2016; 2(9): 1125-6. [Link] [Pubmed]


Hwang TJ, Lauffenburger JL, Franklin JM, Kesselheim AS. Temporal trends and factors associated with cardiovascular drug development, 1990 to 2012. J Am Coll Cardiol BTS 2016; 1(5): 301-8. [Link]


Kesselheim AS, Hwang TJ, Franklin JM. Two decades of new drug development for central nervous system disorders. Nature Rev Drug Discovery 2015; 14(12): 815-816. [Link] [Pubmed]


Hwang TJ, Kesselheim AS. Vaccine pipeline has grown over the past two decades with more early-stage trials from small and medium-sized companies. Health Affairs 2016; 35(2): 219-226. [Link] [Pubmed]


Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow J, Kesselheim AS. Precision medicines have faster approvals based on fewer and smaller trials than other medicines. Health Affairs 2018; 37(5): 724-731. [Link] [Pubmed]


Sinha MS, Jain N, Hwang TJ, Kesselheim AS. Expansion of the priority review voucher program under the 21st Century Cures Act: implications for innovation and public health. Am J Law Med 2018; 44(2): 329-341. [Link] [Pubmed]


Hwang TJ, Kesselheim AS. Analysis: public referendum on drug prices in the US. BMJ 2016; 355: i5657. [Link] [Pubmed]


Hwang TJ, Avorn J, Carpenter D, Kesselheim AS. Quantifying the Food and Drug Administration’s rulemaking delays highlights the need for transparency. Health Affairs 2014; 33(2): 309-315. [Link] [Pubmed]


Hwang TJ, Avorn J, Kesselheim AS. Lifecycle of medical product rules issued by the US Food and Drug Administration. J Health Polit Policy Law 2014; 39(4): 751-780. [Link] [Pubmed]



Hwang TJ, Keshavjee S. Global financing and long-term technical assistance for multidrug-resistant tuberculosis: Scaling up access to treatment. PLOS Med 2014; 11(9): e1001738. [Link] [Pubmed]


Hwang TJ, Dotsenko S, Jafarov A, Weyer K, Falzon D, Lunte K, Nunn P, Jaramillo E, Keshavjee S, Wares DF. 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. BMJ Open 2014; 4(1): e004143. [Link] [Pubmed]


Hwang TJ, Wares DF, Jafarov A, Jakubowiak W, Nunn P, Keshavjee S. Safety of cycloserine and terizidone for the treatment of drug resistant tuberculosis: A meta-analysis. Int J Tuberc Lung Dis 2013; 17(10): 1257-1266. [Link] [Pubmed]


Hwang TJ, Ottmani S, Uplekar M. A rapid assessment of prevailing policies on tuberculosis contact investigation. Int J Tuberc Lung Dis 2011; 15(12): 1620-1623. [Link] [Pubmed]



Sachs RE, Hwang TJ. Increasing the transparency of FDA review to enhance the innovation process. In: Transparency in Health and Health Care (Cambridge University Press, forthcoming).


Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Social media impact of the Food and Drug Administration's drug safety communication messaging about zolpidem: mixed-methods analysis. JMIR Public Health Surveill 2018; 4(1): e1. [Link] [Pubmed]


Hwang TJ. Stock market returns and clinical trial results of investigational compounds: An event study analysis of large biopharmaceutical companies. PLOS ONE 2013; 8(8): e71966. [Link] [Pubmed]