Competency: Instruments: All Types
Rationale for all SNDS, SANDS,EU SNDS, EU SANDS (all human drug types); (VSNDS), (VSANDS) (all veterinary drug types); or for biological drug DIN submissions ☐ New route of administration, dosage form and/or strength ☐ New claims/use, indications, recommended administration or dosage regime ☐ Change in formulation or method of manufacturing with clinical/bio data ☐ Change in drug ... ................
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