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Items: 1 to 50 of 356

1.

Experiences With and Challenges Afforded by Expedited Regulatory Pathways.

Liu S, Kesselheim AS.

Clin Pharmacol Ther. 2019 Apr;105(4):795-797. doi: 10.1002/cpt.1365. No abstract available.

PMID:
30883712
2.

Major Events in the Life Course of New Drugs, 2000-2016.

Beall RF, Hwang TJ, Kesselheim AS.

N Engl J Med. 2019 Mar 14;380(11):e12. doi: 10.1056/NEJMp1806930. No abstract available.

PMID:
30865793
3.

Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.

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

PLoS Med. 2019 Mar 13;16(3):e1002763. doi: 10.1371/journal.pmed.1002763. eCollection 2019 Mar.

4.

Cost Implications of Escalating Intravenous Acetaminophen Use in Children.

Bourgeois FT, Graham DA, Kesselheim AS, Randolph AG.

JAMA Pediatr. 2019 Mar 11. doi: 10.1001/jamapediatrics.2019.0101. [Epub ahead of print] No abstract available.

PMID:
30855654
5.

Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.

Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS.

Health Aff (Millwood). 2019 Feb;38(2):313-319. doi: 10.1377/hlthaff.2018.05330.

PMID:
30715972
6.

New Drug Formulations and Their Respective Generic Entry Dates.

Beall RF, Kesselheim AS, Sarpatwari A.

J Manag Care Spec Pharm. 2019 Feb;25(2):218-224. doi: 10.18553/jmcp.2019.25.2.218.

7.

Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes.

Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS.

JAMA. 2019 Jan 29;321(4):374-384. doi: 10.1001/jama.2018.21364.

PMID:
30694321
8.

Physicians' Perspectives on FDA Approval Standards and Off-Label Drug Marketing.

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

JAMA Intern Med. 2019 Jan 22. doi: 10.1001/jamainternmed.2018.8121. [Epub ahead of print] No abstract available.

PMID:
30667474
9.

Tepid Steps on Drug Pricing.

Sarpatwari A, Kesselheim AS.

JAMA Intern Med. 2019 Jan 22. doi: 10.1001/jamainternmed.2018.6593. [Epub ahead of print] No abstract available.

PMID:
30667462
11.

Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.

Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS.

JAMA Intern Med. 2019 Jan 14. doi: 10.1001/jamainternmed.2018.6417. [Epub ahead of print]

PMID:
30640379
12.

A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.

Sarpatwari A, Gagne JJ, Lu Z, Campbell EG, Carman WJ, Enger CL, Dutcher SK, Jiang W, Kesselheim AS.

J Gen Intern Med. 2019 Mar;34(3):420-428. doi: 10.1007/s11606-018-4791-1. Epub 2019 Jan 10.

PMID:
30632102
13.

Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect.

Fralick M, Sacks CA, Kesselheim AS.

JAMA Intern Med. 2019 Feb 1;179(2):224-230. doi: 10.1001/jamainternmed.2018.6112.

PMID:
30615021
14.

An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

Minssen T, Kesselheim AS, Darrow JJ.

Nat Biotechnol. 2019 Jan 3;37(1):21-22. doi: 10.1038/nbt.4324. No abstract available.

PMID:
30605154
15.

A Method for Approximating Future Entry of Generic Drugs.

Beall RF, Darrow JJ, Kesselheim AS.

Value Health. 2018 Dec;21(12):1382-1389. doi: 10.1016/j.jval.2018.04.1827. Epub 2018 Jun 11.

PMID:
30502781
16.

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
17.

Predictors of Drug Shortages and Association with Generic Drug Prices: A Retrospective Cohort Study.

Dave CV, Pawar A, Fox ER, Brill G, Kesselheim AS.

Value Health. 2018 Nov;21(11):1286-1290. doi: 10.1016/j.jval.2018.04.1826. Epub 2018 May 18.

PMID:
30442275
18.

The US Biosimilar Market: Stunted Growth and Possible Reforms.

Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS.

Clin Pharmacol Ther. 2019 Jan;105(1):92-100. doi: 10.1002/cpt.1285. Epub 2018 Dec 28. Review.

PMID:
30415479
19.

The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry.

Sinha MS, Kesselheim AS.

J Law Med Ethics. 2018 Sep;46(3):806-808. doi: 10.1177/1073110518804246. No abstract available.

PMID:
30336090
20.

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

Gyawali B, Kesselheim AS.

Nat Rev Clin Oncol. 2019 Mar;16(3):147-148. doi: 10.1038/s41571-018-0110-3. No abstract available.

PMID:
30317250
21.

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. 2019 Feb;34(2):195-197. doi: 10.1007/s11606-018-4688-z. No abstract available.

PMID:
30291605
22.

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
23.

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 Nov 1;178(11):1458-1466. doi: 10.1001/jamainternmed.2018.3933.

PMID:
30264138
24.

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
25.

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

Gyawali B, Kesselheim AS, D'Andrea E.

Int J Cancer. 2019 Jan 15;144(2):411-412. doi: 10.1002/ijc.31772. Epub 2018 Oct 26. No abstract available.

PMID:
30152520
26.

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
27.

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
28.

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

Darrow JJ, Beall RF, Kesselheim AS.

Appl Health Econ Health Policy. 2019 Feb;17(1):47-54. doi: 10.1007/s40258-018-0420-8.

PMID:
30141133
29.

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.

30.

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
31.

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. 2019 Jan;42(1):85-93. doi: 10.1007/s40264-018-0703-x.

PMID:
30066315
32.

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

Beall RF, Darrow JJ, Kesselheim AS.

Drug Discov Today. 2019 Jan;24(1):20-25. doi: 10.1016/j.drudis.2018.07.006. Epub 2018 Jul 25.

PMID:
30055271
33.

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 Dec;41(12):1333-1342. doi: 10.1007/s40264-018-0697-4.

PMID:
29987757
34.

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
35.

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
36.

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
37.

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
38.

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.

39.

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
40.

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
41.

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
42.

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
43.

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
44.

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.

45.

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.

46.

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
47.

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
48.

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
49.

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
50.

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.

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