biosimilar initial advisory meeting

(8) The term “biosimilar initial advisory meeting”— (A) means a meeting, if requested, that is limited to— (i) a general discussion regarding whether licensure under section 262(k) of title 42 may be feasible for a particular product; and (ii) if so, general advice on the expected content of the development program; and (B) does not include any meeting that involves substantive review of summary data or full study reports.


21 USC § 379j-51(8)

Scoping language

For purposes of this subpart
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