FDA Amends Regulations for 505(b)(2) Applications and ANDAs-Part I

The FDCA, as Amended by Hatch-Waxman and the MMA The FDA approves new drugs under Section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), codified as amended at Section 355 of title 21 of the U.S. Code (U.S.C.).2 The FDCA and corresponding statutes have been amended multiple times, including by the Drug Price Competition and Patent Term Restoration Act of 1984 (referred to as the Hatch-Waxman Amendments)3 and Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).4 The FDA approves pioneer drugs through standalone new drug applications (NDAs) under 21 U.S.C. 355(b)(1). According to the FDA, an NDA applicant or holder that is developing a use code should not speculate about the protected uses that a generic drug applicant may seek to omit from its labeling. [...]if the NDA holder is required by court order to amend patent information or withdraw a patent from the list, it must submit an amendment to its NDA that includes a copy of the order within 14 days of the date that the order was entered to the CDER's Central Document Room. [...]if the term of a listed patent is extended pursuant to 35 U.S.C. 156(e), the NDA holder must submit on Form FDA 3542 a correction to the expiration date of the patent.