💊FDA Notice on Regulatory Review and Patent Extension for BEYFORTUS
Determination of Regulatory Review Period for Purposes of Patent Extension; BEYFORTUS
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEYFORTUS 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 biological product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The content outlines regulatory review periods for patent extension related to the human biological product BEYFORTUS. Such determinations impact financial planning, innovation timelines, and market exclusivity for businesses in the pharmaceutical sector. Compliance with submission deadlines is crucial for patent applicants and could influence their competitive standing.