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New FDA breakthrough-drug category--implications for patients.
Darrow JJ, Avorn J, Kesselheim AS. Darrow JJ, et al. Among authors: kesselheim as. N Engl J Med. 2014 Mar 27;370(13):1252-8. doi: 10.1056/NEJMhle1311493. N Engl J Med. 2014. PMID: 24670173 Free article. No abstract available.
Drug development and FDA approval, 1938-2013.
Darrow JJ, Kesselheim AS. Darrow JJ, et al. Among authors: kesselheim as. N Engl J Med. 2014 Jun 26;370(26):e39. doi: 10.1056/NEJMp1402114. N Engl J Med. 2014. PMID: 24963591 Free article. No abstract available.
A cross-national comparison of 17 countries' insulin glargine drug labels.
Polinski JM, Kesselheim AS, Seeger JD, Connolly JG, Choudhry NK, Shrank WH. Polinski JM, et al. Among authors: kesselheim as. Pharmacoepidemiol Drug Saf. 2015 Feb;24(2):159-65. doi: 10.1002/pds.3704. Epub 2014 Sep 24. Pharmacoepidemiol Drug Saf. 2015. PMID: 25250724
Expanded access to investigational drugs.
Sarpatwari A, Darrow JJ, Kesselheim AS. Sarpatwari A, et al. Among authors: kesselheim as. N Engl J Med. 2015 Apr 9;372(15):1473-4. doi: 10.1056/NEJMc1501823. N Engl J Med. 2015. PMID: 25853762 No abstract available.
586 results