BraierP. New medicare law brings changes to Hatch–Waxman Act. J Generic Med2004; 1: 268–272.
2.
The MMA applies to both 505(b)(2) applications and generic 505(j) applications (with the exception of the 180-day exclusivity provisions, which do not apply to 505(b)(2) applications).
“Standing” refers to the constitutional requirement that to assert an action in court, a plaintiff must demonstrate that it has been or will be harmed; that the harm be fairly traced to the defendant; and that the harm complained of be of a type the court can address. “Standing” is not necessarily required in administrative proceedings such as the patent dispute procedure.
15.
Also known as “skinny label,” this is where an ANDA or 505(b)(2) has deleted certain information from its version of the product label, typically in order to avoid a patent or exclusivity issue.
16.
21 C.F.R. § 314.95 (c).
17.
21 C.F.R. § 314.95 (b)(1).
18.
21 C.F.R. § 314.95 (b)(2).
19.
21 C.F.R. § 314.95 (g).
20.
This is the author’s belief, and not an endorsement of any delivery company.
