The Committee will discuss new drug application (NDA) 215244, for elamipretide hydrochloride injection, submitted by Stealth BioTherapeutics Inc., for the treatment of Barth Syndrome.
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FDA is conducting a MIDD Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as MIDD approaches.Charles H. Harper, M.D. Norfolk, NE. EIR issued 11/13/2020
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/13/2020
Short Title (70 char) Charles H. Harper, M.D. Norfolk, NE. EIR issued 11/13/2020
FEI Number 3015685119
Firm Name Charles H. Harper, M.D.
Record Type EIR
State NE
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