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The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients.
Kesselheim AS, Choudhry NK. Kesselheim AS, et al. Ann Intern Med. 2008 Apr 15;148(8):614-9. doi: 10.7326/0003-4819-148-8-200804150-00006. Ann Intern Med. 2008. PMID: 18413623
As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription d
As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importati
Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009.
Outterson K, Powers JH, Seoane-Vazquez E, Rodriguez-Monguio R, Kesselheim AS. Outterson K, et al. J Law Med Ethics. 2013 Fall;41(3):688-96. doi: 10.1111/jlme.12079. J Law Med Ethics. 2013. PMID: 24088160
Future policies providing incentives for new antibiotic development should not be based on simple numerical targets and key provisions should ensure appropriate quality as well as quantity of antibiotic drug innovation....
Future policies providing incentives for new antibiotic development should not be based on simple numerical targets and key provisions shoul …
Chemotherapy parity laws: a remedy for high drug costs?
Wang B, Joffe S, Kesselheim AS. Wang B, et al. JAMA Intern Med. 2014 Nov;174(11):1721-2. doi: 10.1001/jamainternmed.2014.4878. JAMA Intern Med. 2014. PMID: 25243936 No abstract available.
Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population.
Kesselheim AS, Franklin JM, Kim SC, Seeger JD, Solomon DH. Kesselheim AS, et al. J Gen Intern Med. 2015 Nov;30(11):1633-8. doi: 10.1007/s11606-015-3285-7. Epub 2015 Apr 9. J Gen Intern Med. 2015. PMID: 25855479 Free PMC article.
OBJECTIVE: We analyzed the impact of the new single-source colchicine product on prescribing and patient health spending as well as incidence rates of potentially dangerous concomitant use of clarithromycin and cyclosporine after formal FDA approval. ...
OBJECTIVE: We analyzed the impact of the new single-source colchicine product on prescribing and patient health spending as well a
Breakthrough Medical Devices and the 21st Century Cures Act.
Kesselheim AS, Hwang TJ. Kesselheim AS, et al. Ann Intern Med. 2016 Apr 5;164(7):500-2. doi: 10.7326/M15-1906. Epub 2016 Jan 19. Ann Intern Med. 2016. PMID: 26785350 No abstract available.
Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals.
Sinha MS, Kesselheim AS. Sinha MS, et al. Bioorg Med Chem. 2016 Dec 15;24(24):6446-6451. doi: 10.1016/j.bmc.2016.08.033. Epub 2016 Aug 22. Bioorg Med Chem. 2016. PMID: 27591793 Review.
Changes to the FDA regulatory approval process include greater reliance on surrogate endpoints such as biomarkers, use of noninferiority hypothesis designs for key preapproval clinical trials, and development of an expedited development track specific for antibiotics calle …
Changes to the FDA regulatory approval process include greater reliance on surrogate endpoints such as biomarkers, use of noninferior …
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. Hwang TJ, et al. JAMA Intern Med. 2016 Dec 1;176(12):1826-1833. doi: 10.1001/jamainternmed.2016.6008. JAMA Intern Med. 2016. PMID: 27723879
Agents were classified by therapeutic area, orphan designation status, fast track designation, novelty of biological pathway, company size, and as a pharmacologic or biologic product. ...
Agents were classified by therapeutic area, orphan designation status, fast track designation, novelty of biological pathway, company size, …
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