💊FDA's Patent Extension Review for ROLVEDON and Its Business Impact
Determination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDON
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROLVEDON 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 FDA's determination on the regulatory review period for ROLVEDON impacts patent extension applications crucial for pharmaceutical companies. Businesses in the biotech and pharmaceutical sectors may need to align with these guidelines for compliance and to potentially benefit from the resulting patent extensions, affecting market strategy and financial forecasting.