16 Jun 2025
💊FDA Notice on Patent Extension for POMBILITI Regulatory Review
Determination of Regulatory Review Period for Purposes of Patent Extension; POMBILITI
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POMBILITI 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 regulation outlines the FDA's determination regarding the regulatory review period for POMBILITI, crucial for companies considering patent term extensions. It highlights compliance requirements related to patent applications and regulatory processes, making it relevant for pharmaceutical businesses.