Federal Register #FDA-2014-E-2328

FDA Notice: Regulatory Review Period Determination for INJECTAFER Patent Extension

This notice from the Food and Drug Administration (FDA) addresses the regulatory review period determination for the drug INJECTAFER, related to a patent extension application. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No OEMs or vendors are solicited; INJECTAFER is referenced as the subject drug - Products/Services Requested: - No procurement of products or services is requested - The notice pertains to the administrative process for patent term extension for U.S. Patent No. 7,612,109 (INJECTAFER) - Unique or Notable Requirements: - The notice details the regulatory review period, including testing and approval phases for INJECTAFER - Public comments and petitions are invited regarding the determination and the applicant's diligence during the review period - This is an administrative action, not a solicitation for goods or services

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the drug INJECTAFER, which is relevant for patent extension purposes. This determination follows a submission to the U.S. Patent and Trademark Office (USPTO) for the extension of a patent claiming this human drug product. The regulatory review period includes both the testing phase and approval phase, with specific dates identified for the investigational new drug application, new drug application submission, and approval. The notice invites comments and petitions regarding the determination and the applicant's diligence during the regulatory review period.

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