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Items: 38

1.

Availability of paediatric information in European Medicines Agency approvals.

Hwang TJ, Tomasi PA, Saint-Raymond A, Bourgeois FT.

Lancet Child Adolesc Health. 2018 May;2(5):e9. doi: 10.1016/S2352-4642(18)30101-9. Epub 2018 Apr 12. No abstract available.

PMID:
30169272
2.

Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.

Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS.

Health Aff (Millwood). 2018 May;37(5):724-731. doi: 10.1377/hlthaff.2017.1580.

PMID:
29733717
3.

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ.

J Clin Oncol. 2018 Jun 20;36(18):1805-1812. doi: 10.1200/JCO.2017.77.1592. Epub 2018 Apr 24.

PMID:
29688832
4.

Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.

Hwang TJ, Tomasi PA, Bourgeois FT.

PLoS Med. 2018 Mar 1;15(3):e1002520. doi: 10.1371/journal.pmed.1002520. eCollection 2018 Mar.

5.

Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.

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.

JMIR Public Health Surveill. 2018 Jan 5;4(1):e1. doi: 10.2196/publichealth.7823.

6.

The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.

Hwang TJ, Darrow JJ, Kesselheim AS.

JAMA. 2017 Dec 5;318(21):2137-2138. doi: 10.1001/jama.2017.14896. No abstract available.

7.

Improving the Study of New Medicines for Children With Rare Diseases.

Bourgeois FT, Hwang TJ.

JAMA Pediatr. 2018 Jan 1;172(1):7-9. doi: 10.1001/jamapediatrics.2017.4012. No abstract available.

PMID:
29131900
8.

Value-Based Pricing and State Reform of Prescription Drug Costs.

Hwang TJ, Kesselheim AS, Sarpatwari A.

JAMA. 2017 Aug 15;318(7):609-610. doi: 10.1001/jama.2017.8255. No abstract available.

PMID:
28692713
9.

Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer.

Davies BJ, Hwang TJ, Kesselheim AS.

N Engl J Med. 2017 Apr 13;376(15):1401-1403. doi: 10.1056/NEJMp1615697. No abstract available.

PMID:
28402764
10.

The Pediatric Research Equity Act Moves Into Adolescence.

Bourgeois FT, Hwang TJ.

JAMA. 2017 Jan 17;317(3):259-260. doi: 10.1001/jama.2016.18131. No abstract available.

PMID:
28114560
11.

Public referendum on drug prices in the US: will it bring relief?

Hwang TJ, Kesselheim AS.

BMJ. 2016 Oct 31;355:i5657. doi: 10.1136/bmj.i5657. No abstract available.

PMID:
27799143
12.

Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results.

Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS.

JAMA Intern Med. 2016 Dec 1;176(12):1826-1833. doi: 10.1001/jamainternmed.2016.6008.

PMID:
27723879
13.

Temporal Trends and Factors Associated With Cardiovascular Drug Development, 1990 to 2012.

Hwang TJ, Lauffenburger JC, Franklin JM, Kesselheim AS.

JACC Basic Transl Sci. 2016 Aug 29;1(5):301-308. doi: 10.1016/j.jacbts.2016.03.012. eCollection 2016 Aug. Review.

14.

Measuring the Value of New Medications and Implications for Medicare's Proposed Part B Drug Payment Model.

Hwang TJ, LaMattina JL.

JAMA Oncol. 2016 Sep 1;2(9):1125-6. doi: 10.1001/jamaoncol.2016.2037. No abstract available.

PMID:
27388928
15.
16.

Leveraging Novel and Existing Pathways to Approve New Therapeutics to Treat Serious Drug-Resistant Infections.

Hwang TJ, Kesselheim AS.

Am J Law Med. 2016 May;42(2-3):429-450. doi: 10.1177/0098858816658275.

PMID:
29086648
17.

Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies.

Hwang TJ, Kesselheim AS.

Health Aff (Millwood). 2016 Feb;35(2):219-26. doi: 10.1377/hlthaff.2015.1073.

PMID:
26858373
18.

Breakthrough Medical Devices and the 21st Century Cures Act.

Kesselheim AS, Hwang TJ.

Ann Intern Med. 2016 Apr 5;164(7):500-2. doi: 10.7326/M15-1906. Epub 2016 Jan 19. No abstract available.

PMID:
26785350
19.

Two decades of new drug development for central nervous system disorders.

Kesselheim AS, Hwang TJ, Franklin JM.

Nat Rev Drug Discov. 2015 Dec;14(12):815-6. doi: 10.1038/nrd4793. Epub 2015 Nov 20. No abstract available.

PMID:
26585536
20.

Antimicrobial stewardship and public knowledge of antibiotics.

Hwang TJ, Gibbs KA, Podolsky SH, Linder JA.

Lancet Infect Dis. 2015 Sep;15(9):1000-1001. doi: 10.1016/S1473-3099(15)00235-2. No abstract available.

PMID:
26333323
21.

Accelerating innovation in rapid diagnostics and targeted antibacterials.

Hwang TJ, Powers JH, Carpenter D, Kesselheim AS.

Nat Biotechnol. 2015 Jun;33(6):589-90. doi: 10.1038/nbt.3251. No abstract available.

PMID:
26057972
22.

Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.

Hwang J, Hwang TJ, Ciolino JB.

BMJ Open. 2015 Jun 4;5(6):e007987. doi: 10.1136/bmjopen-2015-007987.

23.

Precision medicine and the FDA's draft guidance on laboratory-developed tests.

Hwang TJ, Lehmann LS, Kesselheim AS.

Nat Biotechnol. 2015 May;33(5):449-51. doi: 10.1038/nbt.3221. No abstract available.

PMID:
25965745
24.

Paying for innovation: reimbursement incentives for antibiotics.

Hwang TJ, Carpenter D, Kesselheim AS.

Sci Transl Med. 2015 Feb 25;7(276):276fs9. doi: 10.1126/scitranslmed.aaa1429. No abstract available.

PMID:
25717095
25.

Surgical applications of 3-dimensional printing and precision medicine.

Hwang TJ, Kiang C, Paul M.

JAMA Otolaryngol Head Neck Surg. 2015 Apr;141(4):305-6. doi: 10.1001/jamaoto.2015.44. No abstract available.

PMID:
25695233
26.

Retinal implants and Medicare reimbursement policies for breakthrough treatments in ophthalmology.

Hwang TJ, Ciolino JB.

JAMA Ophthalmol. 2015 Apr;133(4):373-4. doi: 10.1001/jamaophthalmol.2015.54. No abstract available.

PMID:
25675029
27.

Global financing and long-term technical assistance for multidrug-resistant tuberculosis: scaling up access to treatment.

Hwang TJ, Keshavjee S.

PLoS Med. 2014 Sep 30;11(9):e1001738. doi: 10.1371/journal.pmed.1001738. eCollection 2014 Sep. Review. No abstract available.

28.

AM last page. Survey of MD/MBA programs: opportunities for physician management education.

Goyal R, Aung KK, Oh B, Hwang TJ, Besancon E, Jain SH.

Acad Med. 2015 Jan;90(1):121. doi: 10.1097/ACM.0000000000000517. No abstract available.

PMID:
25229193
29.

New regulatory paradigms for innovative drugs to treat pediatric diseases.

Hwang TJ, Bourgeois FT.

JAMA Pediatr. 2014 Oct;168(10):879-80. doi: 10.1001/jamapediatrics.2014.904. No abstract available.

30.

Drug safety in the digital age.

Hwang TJ, Bourgeois FT, Seeger JD.

N Engl J Med. 2014 Jun 26;370(26):2460-2. doi: 10.1056/NEJMp1401767. No abstract available.

31.

Target small firms for antibiotic innovation.

Hwang TJ, Carpenter D, Kesselheim AS.

Science. 2014 May 30;344(6187):967-9. doi: 10.1126/science.1251419. No abstract available.

PMID:
24876477
32.

Life cycle of medical product rules issued by the US Food and Drug Administration.

Hwang TJ, Avorn J, Kesselheim AS.

J Health Polit Policy Law. 2014 Aug;39(4):751-80. doi: 10.1215/03616878-2743027. Epub 2014 May 19.

PMID:
24842974
33.

Postmarketing trials and pediatric device approvals.

Hwang TJ, Kesselheim AS, Bourgeois FT.

Pediatrics. 2014 May;133(5):e1197-202. doi: 10.1542/peds.2013-3348. Epub 2014 Apr 14.

34.

Association between fluoroquinolone resistance and resistance to other antimicrobial agents among Escherichia coli urinary isolates in the outpatient setting: a national cross-sectional study.

Hwang TJ, Hooper DC.

J Antimicrob Chemother. 2014 Jun;69(6):1720-2. doi: 10.1093/jac/dku029. Epub 2014 Feb 11. No abstract available.

PMID:
24521853
35.

Quantifying The Food And Drug Administration's rulemaking delays highlights the need for transparency.

Hwang TJ, Avorn J, Carpenter D, Kesselheim AS.

Health Aff (Millwood). 2014 Feb;33(2):309-15. doi: 10.1377/hlthaff.2013.0564.

PMID:
24493775
36.

Assessment of US pathway for approving medical devices for rare conditions.

Hwang TJ, Carpenter D, Kesselheim AS.

BMJ. 2014 Jan 17;348:g217. doi: 10.1136/bmj.g217. Review. No abstract available.

PMID:
24443478
37.

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.

BMJ Open. 2014 Jan 2;4(1):e004143. doi: 10.1136/bmjopen-2013-004143. Review.

38.

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