ABBREVIATED(NEW)DRUG
FDA申报术语
ACCELERATED APPROVAL
ADVERSE EFFECT
AGENCY
ANDA(ABBREVIATED NEW DRUG APPLICATION)
ANIMAL TRIAL
ARCHIVAL COPY
BATCH PRODUCTION
BATCH PRODUCTION RECORDS
BENIFIT(S)
CFR(CODE OF FEDERAL REGULATION)
Dietary supplement
DRUG MASTER FILE
DRUG PRODUCT
DRUG SUBSTANCE
EPA(EXPORT APPLICATION)
ESTABLISHED NAME
FDA(FOOD AND DRUG ADMINISTRATION)
GENERIC NAME
HOLDER
IDENTITY
INDA(INVESTIGATIONAL NEW DRUG APPLICATION)
INFORMED CONSENT
INN(INTERNATIONAL NONPROPRIETARY NAME)
INVESTIGATOR
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