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An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products.
Regul Toxicol Pharmacol. 2020 Feb;110:104511. doi: 10.1016/j.yrtph.2019.104511. Epub 2019 Oct 31.
Regul Toxicol Pharmacol. 2020.
PMID: 31678263
FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.
Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P.
Beaver JA, et al.
Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31.
Clin Cancer Res. 2015.
PMID: 26324739
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