What changed between these versions
A small clarification. Section 27(a)(5)'s definition of "generic drug" was tightened to explicitly state that a (b)(2) application seeks therapeutic equivalence to the "reference product abbreviated new drug application." A minor punctuation correction was also made in Section 27(b)(3)(A).
Overview
A couple of minor changes. · v2 clarifies a specific term within a definition and corrects a minor grammatical error, without altering the overall policy direction or scope of the bill.
The primary change in v2 is a clarification within the definition of "generic drug" in Section 27(a)(5), specifying the target for therapeutic equivalence ratings in certain applications. Additionally, a minor grammatical correction was made in Section 27(b)(3)(A) regarding the enumeration of legal actions. The core prohibitions and enforcement mechanisms against product hopping remain unchanged.
Modifications
This clarification ensures precision in legal interpretation regarding which specific application a 505(b)(2) application seeks therapeutic equivalence to, potentially narrowing ambiguity for regulatory bodies and manufacturers.
Before
Defined "generic drug" as any drug approved under an application submitted under subsection (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or an application under subsection (b)(2) of such section 505 that seeks a therapeutic equivalence rating to the reference product.
After
Defined "generic drug" as any drug approved under an application submitted under subsection (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or an application under subsection (b)(2) of such section 505 that seeks a therapeutic equivalence rating to the reference product abbreviated new drug application.
No substantive operative impact; it improves readability and grammatical correctness.
Before
Referred to legal actions as "action, suit or proceeding initiated by the Commission under subsection (c)(1)".
After
Referred to legal actions as "action, suit, or proceeding initiated by the Commission under subsection (c)(1)".