`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`214187Orig1s000
`
`OFFICER/EMPLOYEE LIST
`
`
`
`
`
`MEMORANDUM
`
`DATE:
`
`June 7, 2021
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`TO:
`
`FROM:
`
`Operations
`
`Administrative file for NDA 214187
`
`Talia Lindheimer, Regulatory Health Project Manager
`Division of Regulatory Operations for Infectious Diseases, Office of Regulatory
`
`SUBJECT: Officer/Employee List for NDA 214187
`
`APPLICATION/DRUG:
`
`NDA 214187, Epclusa, sofosbuvir and velpatasvir, oral pellet
`
`The following officers or employees of FDA participated in the decision to approve this
`application and consented to be identified on this list:
`
`Birnkrant, Debra
`Brooks, Shamika
`Dahmane, Elyes
`El-Kamary, Samer
`Englund, Erika
`Fanari, Melina
`Harrington Patrick
`Kolejian, Sevan
`Lindheimer, Talia
`Mishra, Poonam
`O’Rear Julian
`Oliver, Thomas F
`Ossareh, Nima
`Ou, Mei
`Patel, Paresma
`Tiwari, Rohit
`Vaghasia, Brijeshkumar
`Walker, Morgan
`Wang, Hailin (Sheena)
`Winestock, Karen
`Zheng, Jenny H
`
`Reference ID: 4807243
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`TALIA A LINDHEIMER
`06/07/2021 09:51:21 AM
`
`Reference ID: 4807243
`
`(
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`
`
`