🏥FDA Announces Regulatory Review Period for Chocolate Touch Device
Determination of Regulatory Review Period for Purposes of Patent Extension; [CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER)]
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER) 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 medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulatory notice specifies a regulatory review period and a patent term extension for a medical device, which impacts businesses involved in development and commercialization of medical products. The timeline for patent extensions could affect pricing, competition, and revenues for existing or new market entrants.