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The Four Criteria FDA Balanced Under a 2019 final rule (84 FR 4696), FDA evaluates each nominated substance against four criteria and applies a balancing test — weighing each factor against the others on a substance-by-substance basis: Physical and chemical characterization — is the substance well-defined and controllable

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Size:1000 mcg/ml - 10 ml x 4

Sato T, Amano H, Ito Y, et al