💊FDA Regulatory Review Period Determination for LAMZEDE Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; LAMZEDE
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAMZEDE 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
$$ - Med
The regulation outlines the FDA's determination of the regulatory review period for the patent extension of LAMZEDE. This affects businesses involved in pharmaceuticals and biotechnology, as patent extensions can influence market exclusivity and revenue potential. Companies must be aware of the process for filing comments and petitions, impacting their compliance and regulatory strategies.