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FDA Approval of Desmopressin for Nocturia.
Fralick M, Kesselheim AS. Fralick M, et al. JAMA. 2017 May 23;317(20):2059-2060. doi: 10.1001/jama.2017.4316. JAMA. 2017. PMID: 28384655 No abstract available.
University-based science and biotechnology products: defining the boundaries of intellectual property.
Kesselheim AS, Avorn J. Kesselheim AS, et al. JAMA. 2005 Feb 16;293(7):850-4. doi: 10.1001/jama.293.7.850. JAMA. 2005. PMID: 15713775
The pharmaceutical and biotechnology industries have long relied on patenting as the primary means of allocating ownership and control over new discoveries. ...
The pharmaceutical and biotechnology industries have long relied on patenting as the primary means of allocating ownership and contro …
Biomedical patents and the public's health: is there a role for eminent domain?
Kesselheim AS, Avorn J. Kesselheim AS, et al. JAMA. 2006 Jan 25;295(4):434-7. doi: 10.1001/jama.295.4.434. JAMA. 2006. PMID: 16434634 No abstract available.
The rise and fall of Natrecor for congestive heart failure: implications for drug policy.
Kesselheim AS, Fischer MA, Avorn J. Kesselheim AS, et al. Health Aff (Millwood). 2006 Jul-Aug;25(4):1095-102. doi: 10.1377/hlthaff.25.4.1095. Health Aff (Millwood). 2006. PMID: 16835191
We use it as a case study to assess how FDA standards for drug approval, marketing practices by drug manufacturers, and physicians' prescribing choices can shape the risk-benefit relationship of new drugs. ...
We use it as a case study to assess how FDA standards for drug approval, marketing practices by drug manufacturers, and physicians' p …
The role of litigation in defining drug risks.
Kesselheim AS, Avorn J. Kesselheim AS, et al. JAMA. 2007 Jan 17;297(3):308-11. doi: 10.1001/jama.297.3.308. JAMA. 2007. PMID: 17227983 No abstract available.
Drug development for neglected diseases - the trouble with FDA review vouchers.
Kesselheim AS. Kesselheim AS. N Engl J Med. 2008 Nov 6;359(19):1981-3. doi: 10.1056/NEJMp0806684. N Engl J Med. 2008. PMID: 18987367 No abstract available.
Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.
Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, Shrank WH. Kesselheim AS, et al. JAMA. 2008 Dec 3;300(21):2514-26. doi: 10.1001/jama.2008.758. JAMA. 2008. PMID: 19050195 Free PMC article. Review.
For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. RESULTS: We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). ...
For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. RESULTS: We identified 4 …
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