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Items: 1 to 20 of 27

1.

Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.

Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT.

JAMA Pediatr. 2018 Nov 19. doi: 10.1001/jamapediatrics.2018.3416. [Epub ahead of print]

PMID:
30452498
2.

Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health.

Sinha MS, Jain N, Hwang T, Kesselheim AS.

Am J Law Med. 2018 May;44(2-3):329-341. doi: 10.1177/0098858818789430. No abstract available.

PMID:
30106661
3.

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
4.

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
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.

Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development.

Jain N, Hwang T, Franklin JM, Kesselheim AS.

JAMA. 2017 Jul 25;318(4):388-389. doi: 10.1001/jama.2017.7467. No abstract available.

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.

Challenges in the Development of Novel Cardiovascular Therapies.

Hwang TJ, Kesselheim AS.

Clin Pharmacol Ther. 2017 Aug;102(2):194-196. doi: 10.1002/cpt.703. Epub 2017 Jun 23. Review.

PMID:
28643861
10.

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
11.

Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development.

Hwang TJ, Franklin JM, Kesselheim AS.

Clin Pharmacol Ther. 2017 Aug;102(2):290-296. doi: 10.1002/cpt.705. Epub 2017 May 27. Review.

PMID:
28390139
12.

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
13.

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
14.

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.

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.

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

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