DRUG DISCOVERY DEVELOPMENT (DDD): FDA policy to focused on pts with
clinically significant illnesses who CANNOT BE ENROLLED IN ON-GOING TX TRIALS. → receive tx in an OPEN-LABEL DESIGN before safety and efficacy have been established

Question

FDA policy to focused on pts with
clinically significant illnesses who CANNOT BE ENROLLED IN ON-GOING TX TRIALS. → receive tx in an OPEN-LABEL DESIGN before safety and efficacy have been established

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Parallel track

DRUG DISCOVERY DEVELOPMENT (DDD)

FDA policy to focused on pts with clinically significant illnesses who CANNOT BE ENROLLED IN ON-GOING TX TRIALS. → receive tx in an OPEN-LABEL DESIGN before safety and efficacy have been established

Parallel track

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