💊FDA Notice on Patent Extension for VAFSEO Drug Regulations
Determination of Regulatory Review Period for Purposes of Patent Extension; VAFSEO
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VAFSEO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 involves the FDA's determination of the regulatory review period for a drug patent extension. This has significant financial implications for companies considering patent extensions, as it allows them potential additional years of market exclusivity for their products. Business owners must be aware of deadlines for petitions and comments which may affect their patent applications.