Notice 20 Jun 2025 healthcare, pharmaceuticals, fda, regulatory review, biologics, patent extension

💊FDA Patent Extension Notice for COLUMVI

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for COLUMVI 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 20 Jun 2025 healthcare, pharmaceuticals, fda, regulatory review, patent extension, zilbrysq

💊FDA Determines Regulatory Review Period for ZILBRYSQ Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZILBRYSQ 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 drug product.

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Notice 20 Jun 2025 pharmaceuticals, fda, regulatory review, patent extension, biogen, qalsody

💊FDA Determines Regulatory Review Period for QALSODY Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QALSODY 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 drug product.

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Notice 16 Jun 2025 regulatory compliance, healthcare, pharmaceuticals, fda, biotechnology, patent extension

💊FDA's Patent Extension Review for ROLVEDON and Its Business Impact

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROLVEDON 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 human biological product.

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Notice 16 Jun 2025 compliance, pharmaceuticals, fda, regulatory review, patent extension, befortus

💊FDA Notice on Regulatory Review and Patent Extension for BEYFORTUS

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEYFORTUS 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 16 Jun 2025 pharmaceuticals, fda, regulatory review, patent extension, pombiliti

💊FDA Notice on Patent Extension for POMBILITI Regulatory Review

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POMBILITI 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 human biological product.

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Notice 16 Jun 2025 compliance, regulatory, pharmaceuticals, fda, veterinary, animal drugs

🐾FDA Notice on Abbreviated New Animal Drug Applications

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of abbreviated new animal drug applications.

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Notice 16 Jun 2025 regulations, business strategy, pharmaceuticals, fda, patent extension

💊FDA Determination of Regulatory Review Period for ZEVTERA Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEVTERA 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 human drug product.

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Notice 16 Jun 2025 healthcare, regulation, pharmaceuticals, fda, drug approval, patent extension

💊FDA's Determination of Regulatory Review Period for RIVFLOZA

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RIVFLOZA 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 human drug product.

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Notice 16 Jun 2025 pharmaceuticals, fda, regulatory review, health, patent extension, voydeya

💊FDA Determines Regulatory Review Period for VOYDEYA Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOYDEYA 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 human drug product.

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