💊FDA Regulatory Review Period Determination for SOFDRA
Determination of Regulatory Review Period for Purposes of Patent Extension; SOFDRA
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOFDRA 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 claim that human drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document discusses the FDA's determination of the regulatory review period for SOFDRA, impacting patent extension for the drug, which can influence market exclusivity and financial returns for the patent holder and potential competitors. It establishes timelines for comments and petitions affecting business planning in the pharmaceutical sector.