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Drug development and FDA approval, 1938-2013.
Darrow JJ, Kesselheim AS. Darrow JJ, et al. N Engl J Med. 2014 Jun 26;370(26):e39. doi: 10.1056/NEJMp1402114. N Engl J Med. 2014. PMID: 24963591 No abstract available.
Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.
Darrow JJ, Avorn J, Kesselheim AS. Darrow JJ, et al. N Engl J Med. 2017 Dec 7;377(23):2278-2286. doi: 10.1056/NEJMhle1710706. N Engl J Med. 2017. PMID: 29211663 No abstract available.
The FDA Breakthrough-Drug Designation - Four Years of Experience.
Darrow JJ, Avorn J, Kesselheim AS. Darrow JJ, et al. N Engl J Med. 2018 Apr 12;378(15):1444-1453. doi: 10.1056/NEJMhpr1713338. N Engl J Med. 2018. PMID: 29641970 No abstract available.
A Method for Approximating Future Entry of Generic Drugs.
Beall RF, Darrow JJ, Kesselheim AS. Beall RF, et al. Value Health. 2018 Dec;21(12):1382-1389. doi: 10.1016/j.jval.2018.04.1827. Epub 2018 Jun 11. Value Health. 2018. PMID: 30502781
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