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Regulatory Considerations in the Approval of Rezafungin (REZZAYO) for the Treatment of Candidemia and Invasive Candidiasis in Adults.
Smith HL, Bensman TJ, Mishra S, Li X, Dixon CA, Sheikh J, McMaster OG, Joshi A, Rubin DB, Goodwin A, Miller TJ, Danielsen ZY, Syed I, Shukla SJ, Iarikov D, Kim PW, Farley JJ. Smith HL, et al. Among authors: farley jj. J Infect Dis. 2024 Mar 19:jiae146. doi: 10.1093/infdis/jiae146. Online ahead of print. J Infect Dis. 2024. PMID: 38502709
FDA Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development.
Jjingo CJ, Bala S, Waack U, Needles M, Bensman TJ, McMaster O, Smith T, Blakely B, Chan IZ, Puthawala K, Dixon C, Kim Y, Lim R, Colangelo P, St Clair C, Nambiar S, Moss RB, Botgros R, Bazaz R, Denning DW, Marr KA, Husain S, Berman L, Christensen DJ, Keywood C, Clayton RG, Walsh TJ, Song HSE, Shukla SJ, Farley JJ. Jjingo CJ, et al. Among authors: farley jj. Clin Infect Dis. 2023 Oct 6:ciad607. doi: 10.1093/cid/ciad607. Online ahead of print. Clin Infect Dis. 2023. PMID: 37802928
Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need.
Yasinskaya Y, Bala S, Waack U, Dixon C, Higgins K, Moore JN, Jjingo CJ, O'Shaughnessy E, Colangelo P, Botgros R, Nambiar S, Angulo D, Dane A, Chiller T, Hodges MR, Sandison T, Hope W, Walsh TJ, Pappas P, Katragkou A, Kovanda L, Rex JH, Marr KA, Ostrosky-Zeichner L, Sekine S, Deshpande M, Shukla SJ, Farley J. Yasinskaya Y, et al. Clin Infect Dis. 2023 Aug 14;77(3):380-387. doi: 10.1093/cid/ciad195. Clin Infect Dis. 2023. PMID: 37021650
FDA Public Workshop Summary-Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal Drugs.
O'Shaughnessy E, Yasinskaya Y, Dixon C, Higgins K, Moore J, Reynolds K, Ampel NM, Angulo D, Blair JE, Catanzaro A, Galgiani JN, Garvey E, Johnson R, Larwood DJ, Lewis G, Purdie R, Rex JH, Shubitz LF, Stevens DA, Page SJ, Shukla SJ, Farley JJ, Nambiar S. O'Shaughnessy E, et al. Among authors: farley jj. Clin Infect Dis. 2022 Jun 10;74(11):2061-2066. doi: 10.1093/cid/ciab904. Clin Infect Dis. 2022. PMID: 34651656
FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development.
Byrne JM, Waack U, Weinstein EA, Joshi A, Shurland SM, Iarikov D, Bulitta JB, Diep BA, Guina T, Hope WW, Lawrenz MB, Lepak AJ, Luna BM, Miesel L, Phipps AJ, Walsh TJ, Weiss W, Amini T, Farley JJ. Byrne JM, et al. Among authors: farley jj. Antimicrob Agents Chemother. 2020 Dec 16;65(1):e01983-20. doi: 10.1128/AAC.01983-20. Print 2020 Dec 16. Antimicrob Agents Chemother. 2020. PMID: 33106262 Free PMC article. Review.
Consensus on Language for Advance Informed Consent in Health Care-Associated Pneumonia Clinical Trials Using a Delphi Process.
Corneli A, Calvert SB, Powers JH 3rd, Swezey T, Collyar D, Perry B, Farley JJ, Santiago J, Donnelly HK, De Anda C, Blanchard K, Fowler VG Jr, Holland TL. Corneli A, et al. Among authors: farley jj. JAMA Netw Open. 2020 May 1;3(5):e205435. doi: 10.1001/jamanetworkopen.2020.5435. JAMA Netw Open. 2020. PMID: 32442291 Free PMC article.
36 results