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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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This multi-pathway approach makes it uniquely valuable for researchers studying comprehensive tissue regeneration where wound healing, collagen synthesis, and cellular migration need to occur together