| http://www.w3.org/ns/prov#value | - Information on the approximate kind, degree, and duration of improvement to be anticipated must be stated if available and for all drugs except biological products must be based on substantial evidence derived from adequate and well-controlled studies as defined in ?? 314.126(b) of this chapter unless the requirement is waived under ?? 201.58 or ?? 314.126(c) of this chapter.
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