Drug Products Approved in Abbreviated New Drug Applications Before the Enactment of the Hatch-Waxman Amendments; Establishment of a Public Docket; Request for Comments

摘要

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit comments on several issues related to FDA's post-approval regulation of certain drug products approved in abbreviated applications before the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish the current abbreviated new drug application (ANDA) process. Because these pre-Hatch-Waxman abbreviated new drug applications (referred to in this notice as "PANDAs") were submitted and approved under the provisions of the FD&C Act that apply to 505(b) new drug applications, they can serve as a reference listed drug (RLD) for ANDAs and can also be a listed drug relied on by 505(b)(2) applications. PANDAs have historically been overseen by FDA's Office of Generic Drugs, and FDA is aware that there may be some confusion about the applicability of certain statutory and regulatory provisions to PANDAs. FDA is seeking input from holders of PANDAs and other interested persons regarding whether there are regulatory or policy rationales for treating PANDAs differently from other 505