product information

Defined in 1 dictionary — U.S. Code

United States Code

21 U.S.C. § 352 — in this section (5 versions over time)

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.