💊FDA Regulatory Review Period for HEMGENIX Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; HEMGENIX
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for HEMGENIX and is publishing this notice of that determination as required by law. FDA has made the determination 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 biological product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The notice discusses the FDA's determination regarding the regulatory review period for HEMGENIX, which has direct implications for patent extension affecting the financial interests of biopharmaceutical companies. This could influence strategic decisions regarding investment and market positioning for related businesses.