Federal Register
Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC- Facts included
- The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC.
- FDA is publishing this notice of that determination as required by law.
- The determination was made because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
- Sourcing
- High – the information comes directly from an official FDA notice, which is a primary source for regulatory actions.
- Framing
- The text is a straightforward factual notice without editorial commentary or opinion.
- Omissions
- The notice does not provide the length of the regulatory review period, the criteria used to calculate it, the implications for the patent term extension, or any commentary from the drug manufacturer or other stakeholders.
- Rhetorical notes (2)
- Neutral language · Legal framing