LABELED AMOUNT
FDA申报术语
NARRATIVE SUMMARY
NCE (NEW CHEMICAL ENTITY)
NDA(NEW DRUG APPLICATION)
NF(NATIONAL FORMULARY)
NIH(NATIONAL INSTITUTE OF HEALTH)
ODE (ORPHAN DRUG EXCLUSIVITY)
OFFICIAL COMPENDIUM
OFFICIAL=PHARMACOPEIAL= COMPENDIAL
OTC DRUG(OVER—THE—COUNTER DRUG)
PANEL
POST-OR PRE- MARKET SURVEILLANCE
PREPARING AND SUBMITTING
PROPRIETARY NAME
PROTOCOL
REGULATORY METHODOLOGY
REGULATORY METHODS VALIDATION
REGULATORY SPECIFICATION
REVIEW COPY
RISK(S)
SPONSOR
STANDARD DRUG
STRENGTH
SUBMISSION
TREATMENT IND
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