Notice 14 Jul 2025 regulation, business compliance, pharmaceuticals, fda, patent extension, human biological products

💊FDA Announces Regulatory Review Period for IMDELLTRA Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMDELLTRA 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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Notice 2 Jul 2025 regulations, fda, pharmaceutical, patent extension, human biological products, winrevair

💊FDA Patent Extension Notice for WINREVAIR

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for WINREVAIR 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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Notice 14 May 2025 regulatory compliance, pharmaceuticals, fda, biotechnology, patent extension, human biological products

💊FDA Determination on EPKINLY Patent Extension and Regulatory Review

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPKINLY 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 patents which claims that human biological product.

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