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WebMANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5210.5 Rev. 3 Originator: Office of Generic Drugs Effective Date: … WebNov 11, 2024 · BV-2 microglial cells (purchased from China Center for Type Culture Collection) were cultured in high-glucose Dulbecco's modified Eagle medium (Thermo Fisher Scientific, Inc., Waltham, MA, USA) supplemented with 10% fetal bovine serum (BioInd, Inc., Shanghai, China) and 1% penicillin/streptomycin (Solarbio Science & Technology … WebFeb 5, 2024 · Bio-INDs are investigational new drug applications (INDs) submitted for bioavailability (BA) or bioequivalence (BE) studies under 21 CFR 320.31. The Bio-IND is required by regulations in specific instances to ensure that proposed drug products that contain no-new chemical entities are safe for use in human test subjects and do not … photo of self with id