💊FDA Notice on LUMISIGHT Patent Extension Review Period
Determination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHT
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUMISIGHT 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 drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The content discusses the determination of a regulatory review period for LUMISIGHT, impacting potential patent extensions. This influences business strategies for companies like Lumicell, as patent extensions can provide exclusivity and market advantage. The notice specifies avenues for public comments, directly engaging stakeholders in compliance and positioning for patent negotiations.