product information

(2) For purposes of this paragraph, the term “product information” includes— (A) information describing the drug or device (such as drug class, device description, and features); (B) information about the indication or indications being investigated; (C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 355 , 360(k) , 360c , or 360e of this title or section 262 of title 42 ; (D) drug or device pricing information; (E) patient utilization projections; (F) product-related programs or services; and (G) factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.

Source

21 USC § 352(gg)(2)


Scoping language

For purposes of this paragraph
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