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- B3172037ee301e960816b16f8a874d5ea NCIT_P378 "FDA" @default.
- B3172037ee301e960816b16f8a874d5ea NCIT_P381 "eCTD" @default.
- B3172037ee301e960816b16f8a874d5ea type Axiom @default.
- B3172037ee301e960816b16f8a874d5ea annotatedProperty NCIT_P325 @default.
- B3172037ee301e960816b16f8a874d5ea annotatedSource NCIT_C97027 @default.
- B3172037ee301e960816b16f8a874d5ea annotatedTarget "Prior Approval (PA) "Prior Approval Supplements" supplement submission for a major change for which distribution of the product made using the change cannot occur prior to FDA approval as provided in 21 CFR 314.70 and 21 CFR 601.12." @default.