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Determination of Regulatory Review Period for Purposes of Patent Extension; IMLYGIC

The Food and Drug Administration (FDA) has determined the regulatory review period for IMLYGIC and is publishing this notice of that determination as required by law. FDA has ma...

The Food and Drug Administration (FDA) has determined the regulatory review period for IMLYGIC 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.

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Federal Register Citation

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81 FR 95618

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“Determination of Regulatory Review Period for Purposes of Patent Extension; IMLYGIC,” thefederalregister.org (December 28, 2016), https://thefederalregister.org/documents/2016-31322/determination-of-regulatory-review-period-for-purposes-of-patent-extension-imlygic.