🩺FDA Notice on TRICLIP Regulatory Review Period and Patent Extension
Determination of Regulatory Review Period for Purposes of Patent Extension; TRICLIP
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRICLIP 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 medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulatory determination regarding TRICLIP's review period directly affects potential patent extensions, which can impact business strategies and financial forecasting for Abbott Cardiovascular Systems Inc. The notice outlines the regulatory framework that could affect innovation timelines and market exclusivity for medical devices.