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- Bd53e581eb9a483f72ec23baf67e204ff NCIT_P378 "FDA" @default.
- Bd53e581eb9a483f72ec23baf67e204ff NCIT_P381 "eCTD" @default.
- Bd53e581eb9a483f72ec23baf67e204ff type Axiom @default.
- Bd53e581eb9a483f72ec23baf67e204ff annotatedProperty NCIT_P325 @default.
- Bd53e581eb9a483f72ec23baf67e204ff annotatedSource NCIT_C97027 @default.
- Bd53e581eb9a483f72ec23baf67e204ff 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.