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Will inter partes review speed US generic drug entry?
Darrow JJ, Beall RF, Kesselheim AS. Darrow JJ, et al. Nat Biotechnol. 2017 Dec 8;35(12):1139-1141. doi: 10.1038/nbt.4036. Nat Biotechnol. 2017. PMID: 29220017 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.
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