Preparing for safety issues following drug approval: pre-approval risk management considerations
نویسندگان
چکیده
منابع مشابه
Drug Safety Unscrambling Post - Approval Drug Safety Monitoring
Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...
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ژورنال
عنوان ژورنال: Therapeutic Advances in Drug Safety
سال: 2013
ISSN: 2042-0986,2042-0994
DOI: 10.1177/2042098613498091