Chambers W - Search Results

1

FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.

Merino M, Kasamon Y, Li H, Ma L, Leong R, Zhou J, Reaman G, Chambers W, Richardson N, Theoret M, Pazdur R, Gormley N. Merino M, et al. Among authors: chambers w. Pediatr Blood Cancer. 2022 Aug;69(8):e29602. doi: 10.1002/pbc.29602. Epub 2022 May 13. Pediatr Blood Cancer. 2022. PMID: 35561013

2

FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.

Fallah J, Brave MH, Weinstock C, Mehta GU, Bradford D, Gittleman H, Bloomquist EW, Charlab R, Hamed SS, Miller CP, Dorff SE, Chambers WA, Mixter BD, Dinin J, Pierce WF, Ricks TK, Tang S, Donoghue M, Pazdur R, Amiri-Kordestani L, Ibrahim A, Beaver JA. Fallah J, et al. Among authors: chambers wa. Clin Cancer Res. 2022 Nov 14;28(22):4843-4848. doi: 10.1158/1078-0432.CCR-22-1054. Clin Cancer Res. 2022. PMID: 35727604 Free PMC article.

3

Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine.

Sun H, Temeck JW, McCune SK, Chambers WA. Sun H, et al. Among authors: chambers wa. JAMA Ophthalmol. 2021 Feb 1;139(2):214-217. doi: 10.1001/jamaophthalmol.2020.5558. JAMA Ophthalmol. 2021. PMID: 33331874 Free PMC article. Review.

4

Association of Daratumumab Use With Ocular Events in a Case Series of US Adults.

Nadeau Nguyen M, Chambers W, Dores GM, Nayernama A, Jones SC. Nadeau Nguyen M, et al. Among authors: chambers w. JAMA Oncol. 2022 Aug 1;8(8):1209-1210. doi: 10.1001/jamaoncol.2022.1634. JAMA Oncol. 2022. PMID: 35653128 Free PMC article.

5

Food and Drug Administration approval process for ophthalmic drugs in the US.

Lloyd R, Harris J, Wadhwa S, Chambers W. Lloyd R, et al. Among authors: chambers w. Curr Opin Ophthalmol. 2008 May;19(3):190-4. doi: 10.1097/ICU.0b013e3282f97fa1. Curr Opin Ophthalmol. 2008. PMID: 18408492 Review.

6

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned.

Sun H, Temeck JW, Chambers W, Perkins G, Bonnel R, Murphy D. Sun H, et al. Among authors: chambers w. Ther Innov Regul Sci. 2017;2017:1-7. doi: 10.1177/2168479017725558. Epub 2017 Aug 18. Ther Innov Regul Sci. 2017. PMID: 28890858 Free PMC article.

7

Development of a Retinopathy of Prematurity Activity Scale and Clinical Outcome Measures for Use in Clinical Trials.

Smith LEH, Hellström A, Stahl A, Fielder A, Chambers W, Moseley J, Toth C, Wallace D, Darlow BA, Aranda JV, Hallberg B, Davis JM; Retinopathy of Prematurity Workgroup of the International Neonatal Consortium. Smith LEH, et al. Among authors: chambers w. JAMA Ophthalmol. 2019 Mar 1;137(3):305-311. doi: 10.1001/jamaophthalmol.2018.5984. JAMA Ophthalmol. 2019. PMID: 30543348 Free PMC article.

8

Pentosan associated retinal pigmentary changes: FDA's perspective on an emerging postmarketing safety finding.

Lardieri A, Konkel K, McCulley L, Jones SC, Moeny D, Nguyen C, Sewell C, Chambers W, Ajao A. Lardieri A, et al. Among authors: chambers w. Int Urogynecol J. 2021 Nov;32(11):2891-2897. doi: 10.1007/s00192-021-04970-0. Epub 2021 Sep 10. Int Urogynecol J. 2021. PMID: 34505923

9

Trials and tribulations: a primer on successfully navigating the waters of the Food and Drug Administration.

Feinsod M, Chambers WA. Feinsod M, et al. Ophthalmology. 2004 Oct;111(10):1801-6. doi: 10.1016/j.ophtha.2004.05.022. Ophthalmology. 2004. PMID: 15465539

10

Food and Drug Administration Procedures for New Drug and Device Approvals.

Holland GN, Eydelman MB, Cunningham B, Chambers WA. Holland GN, et al. Am J Ophthalmol. 2016 Jan;161:1-3. doi: 10.1016/j.ajo.2015.11.022. Am J Ophthalmol. 2016. PMID: 26699740 No abstract available.

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