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Items: 1 to 50 of 318

1.

The promise of ESCAT: a new system for evaluating cancer drug-target pairs.

Gyawali B, Kesselheim AS.

Nat Rev Clin Oncol. 2018 Oct 13. doi: 10.1038/s41571-018-0110-3. [Epub ahead of print] No abstract available.

PMID:
30317250
2.

Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate.

Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.

J Gen Intern Med. 2018 Oct 5. doi: 10.1007/s11606-018-4688-z. [Epub ahead of print] No abstract available.

PMID:
30291605
3.

A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway.

Feldman WB, Hey SP, Kesselheim AS.

Health Aff (Millwood). 2018 Oct;37(10):1605-1614. doi: 10.1377/hlthaff.2018.0501.

PMID:
30273035
4.

Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.

Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS.

JAMA Intern Med. 2018 Sep 24. doi: 10.1001/jamainternmed.2018.3933. [Epub ahead of print]

PMID:
30264138
5.

Changes in Drug Pricing After Drug Shortages in the United States.

Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH.

Ann Intern Med. 2018 Sep 18. doi: 10.7326/M18-1137. [Epub ahead of print] No abstract available.

PMID:
30242373
6.

Does Helicobacter pylori eradication therapy to prevent gastric cancer increase all-cause mortality?

Gyawali B, Kesselheim AS, D'Andrea E.

Int J Cancer. 2018 Aug 28. doi: 10.1002/ijc.31772. [Epub ahead of print]

PMID:
30152520
7.

Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. ยง 1498 and Evzio.

Wang A, Kesselheim AS.

J Law Med Ethics. 2018 Jun;46(2):472-484. doi: 10.1177/1073110518782954.

PMID:
30146993
8.

Defining "True and Non-Misleading" for Pharmaceutical Promotion.

Hey SP, Kesselheim AS.

J Law Med Ethics. 2018 Jun;46(2):552-554. doi: 10.1177/1073110518782970. No abstract available.

PMID:
30146990
9.

The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents.

Darrow JJ, Beall RF, Kesselheim AS.

Appl Health Econ Health Policy. 2018 Aug 24. doi: 10.1007/s40258-018-0420-8. [Epub ahead of print]

PMID:
30141133
10.

Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents.

Sacks CA, Lee CC, Kesselheim AS, Avorn J.

JAMA. 2018 Aug 21;320(7):650-656. doi: 10.1001/jama.2018.11439.

PMID:
30140875
11.

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
12.

Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System.

Rogers JR, Sarpatwari A, Desai RJ, Bohn JM, Khan NF, Kesselheim AS, Fischer MA, Gagne JJ, Connolly JG.

Drug Saf. 2018 Aug 1. doi: 10.1007/s40264-018-0703-x. [Epub ahead of print]

PMID:
30066315
13.

Patent term restoration for top-selling drugs in the United States.

Beall RF, Darrow JJ, Kesselheim AS.

Drug Discov Today. 2018 Jul 25. pii: S1359-6446(18)30141-7. doi: 10.1016/j.drudis.2018.07.006. [Epub ahead of print]

PMID:
30055271
14.

Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015.

Mundkur ML, Franklin J, Huybrechts KF, Fischer MA, Kesselheim AS, Linder JA, Landon J, Patorno E.

Drug Saf. 2018 Jul 9. doi: 10.1007/s40264-018-0697-4. [Epub ahead of print]

PMID:
29987757
15.

Reinforcing the social compromise of accelerated approval.

Gyawali B, Kesselheim AS.

Nat Rev Clin Oncol. 2018 Oct;15(10):596-597. doi: 10.1038/s41571-018-0066-3. No abstract available.

PMID:
29970919
16.

Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem.

Luo J, Kesselheim AS.

JAMA Intern Med. 2018 May 1;178(5):721-722. doi: 10.1001/jamainternmed.2018.0989. No abstract available.

PMID:
29801126
17.

An Incomplete Prescription: President Trump's Plan to Address High Drug Prices.

Sarpatwari A, Avorn J, Kesselheim AS.

JAMA. 2018 Jun 19;319(23):2373-2374. doi: 10.1001/jama.2018.7424. No abstract available.

PMID:
29800027
18.

The Shortage of Normal Saline in the Wake of Hurricane Maria.

Sacks CA, Kesselheim AS, Fralick M.

JAMA Intern Med. 2018 Jul 1;178(7):885-886. doi: 10.1001/jamainternmed.2018.1936. No abstract available.

PMID:
29799949
19.

The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.

Sinha MS, Kesselheim AS.

PLoS Med. 2018 May 8;15(5):e1002564. doi: 10.1371/journal.pmed.1002564. eCollection 2018 May.

20.

Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market Exclusivity Period.

Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS.

Health Aff (Millwood). 2018 May;37(5):732-737. doi: 10.1377/hlthaff.2017.1179.

PMID:
29733729
21.

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
22.

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
23.

The FDA Breakthrough-Drug Designation - Four Years of Experience.

Darrow JJ, Avorn J, Kesselheim AS.

N Engl J Med. 2018 Apr 12;378(15):1444-1453. doi: 10.1056/NEJMhpr1713338. No abstract available.

PMID:
29641970
24.

U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.

Lee TT, Kesselheim AS.

Ann Intern Med. 2018 May 15;168(10):730-732. doi: 10.7326/M17-2715. Epub 2018 Apr 10.

PMID:
29632953
25.

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study.

Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ.

BMJ. 2018 Apr 3;361:k1180. doi: 10.1136/bmj.k1180.

26.

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS.

BMJ. 2018 Mar 19;360:k831. doi: 10.1136/bmj.k831.

27.

Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety.

Fralick M, Avorn J, Franklin JM, Bartsch E, Abdurrob A, Kesselheim AS.

J Gen Intern Med. 2018 Jun;33(6):792-794. doi: 10.1007/s11606-018-4349-2. No abstract available.

PMID:
29520746
28.

Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.

Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS.

Drugs. 2018 Mar;78(4):523-524. doi: 10.1007/s40265-018-0890-x.

PMID:
29520639
29.

Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?

Powers JH, Evans SR, Kesselheim AS.

BMJ. 2018 Feb 22;360:k587. doi: 10.1136/bmj.k587. No abstract available.

PMID:
29472192
30.

Application and impact of run-in studies.

Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS.

J Gen Intern Med. 2018 May;33(5):759-763. doi: 10.1007/s11606-018-4344-7. Epub 2018 Feb 15.

PMID:
29450684
31.

Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov.

Bothwell LE, Avorn J, Khan NF, Kesselheim AS.

BMJ Open. 2018 Feb 10;8(2):e018320. doi: 10.1136/bmjopen-2017-018320. Review.

32.

Legal Challenges to State Drug Pricing Laws.

Lee TT, Kesselheim AS, Kapczynski A.

JAMA. 2018 Mar 6;319(9):865-866. doi: 10.1001/jama.2017.20952. No abstract available.

PMID:
29435585
33.

Tertiary patenting on drug-device combination products in the United States.

Beall RF, Kesselheim AS.

Nat Biotechnol. 2018 Feb 6;36(2):142-145. doi: 10.1038/nbt.4078. No abstract available.

PMID:
29406508
34.

Research ethics for emerging trial designs: does equipoise need to adapt?

Hey SP, Weijer C, Taljaard M, Kesselheim AS.

BMJ. 2018 Jan 25;360:k226. doi: 10.1136/bmj.k226. No abstract available.

PMID:
29371211
35.

Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.

Sinha MS, Kesselheim AS, Darrow JJ.

Chest. 2018 Jan;153(1):9-11. doi: 10.1016/j.chest.2017.09.048. No abstract available.

PMID:
29307432
36.

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.

37.

Prices of Generic Drugs Associated with Numbers of Manufacturers.

Dave CV, Hartzema A, Kesselheim AS.

N Engl J Med. 2017 Dec 28;377(26):2597-2598. doi: 10.1056/NEJMc1711899. No abstract available.

38.

Evidence Required for Drugs Granted Accelerated Approval-Reply.

Naci H, Kesselheim AS.

JAMA. 2017 Dec 26;318(24):2493-2494. doi: 10.1001/jama.2017.17184. No abstract available.

PMID:
29279923
39.

Prevalence of Publicly Available Expanded Access Policies.

Jung E, Zettler PJ, Kesselheim AS.

Clin Pharmacol Ther. 2017 Dec 22. doi: 10.1002/cpt.996. [Epub ahead of print]

PMID:
29271014
40.

The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health.

Darrow JJ, Fuse Brown EC, Kesselheim AS.

N Engl J Med. 2018 Feb 1;378(5):412-414. doi: 10.1056/NEJMp1711643. Epub 2017 Dec 20. No abstract available.

PMID:
29261363
41.

Massachusetts' Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage?

Sommers BD, Kesselheim AS.

N Engl J Med. 2018 Jan 11;378(2):109-111. doi: 10.1056/NEJMp1714824. Epub 2017 Dec 13. No abstract available.

PMID:
29236573
42.

Will inter partes review speed US generic drug entry?

Darrow JJ, Beall RF, Kesselheim AS.

Nat Biotechnol. 2017 Dec 8;35(12):1139-1141. doi: 10.1038/nbt.4036. No abstract available.

PMID:
29220017
43.

Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.

Darrow JJ, Avorn J, Kesselheim AS.

N Engl J Med. 2017 Dec 7;377(23):2278-2286. doi: 10.1056/NEJMhle1710706. No abstract available.

PMID:
29211663
44.

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.

45.

The Real-World Ethics of Adaptive-Design Clinical Trials.

Bothwell LE, Kesselheim AS.

Hastings Cent Rep. 2017 Nov;47(6):27-37. doi: 10.1002/hast.783.

PMID:
29171051
46.

Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.

Sarpatwari A, Lee MP, Gagne JJ, Lu Z, Dutcher SK, Jiang W, Campbell EG, Kesselheim AS.

Clin Pharmacol Ther. 2018 Jun;103(6):1093-1099. doi: 10.1002/cpt.884. Epub 2017 Nov 22.

PMID:
29165800
47.

Use of Health Care Databases to Support Supplemental Indications of Approved Medications.

Fralick M, Kesselheim AS, Avorn J, Schneeweiss S.

JAMA Intern Med. 2018 Jan 1;178(1):55-63. doi: 10.1001/jamainternmed.2017.3919.

48.

The Price of Crossing the Border for Medications.

Fralick M, Avorn J, Kesselheim AS.

N Engl J Med. 2017 Oct 26;377(17):1699-1700. doi: 10.1056/NEJMc1711278. No abstract available.

PMID:
29069557
49.

Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States.

Alpern JD, Zhang L, Stauffer WM, Kesselheim AS.

Clin Infect Dis. 2017 Nov 13;65(11):1848-1852. doi: 10.1093/cid/cix634.

PMID:
29020146
50.

Low-Dose Desmopressin Nasal Spray and FDA Approval-Reply.

Fralick M, Kesselheim AS.

JAMA. 2017 Sep 19;318(11):1071-1072. doi: 10.1001/jama.2017.11343. No abstract available.

PMID:
28975301

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