Notice 26 Aug 2025 compliance, pharmaceuticals, fda, regulatory review, patent extension

💊FDA Announces Regulatory Review Period for YORVIPATH Patent Extension

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

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Notice 26 Aug 2025 healthcare, fda, regulatory review, drug approval, patent extension

💊FDA Notice on LUMISIGHT Patent Extension Review Period

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUMISIGHT 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 26 Aug 2025 business compliance, pharmaceuticals, fda, regulatory review, patent extension, piasky

💊FDA Notice on Regulatory Review Period and Patent Extension for PIASKY

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PIASKY 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 26 Aug 2025 fda, regulatory review, biotechnology, patent extension, camzyos

💊FDA Notice on CAMZYOS Patent Extension and Review Period

The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulatory review period of the biologic product CAMZYOS (U.S. patent numbers 9,181,200; 9,585,883) in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.

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Notice 26 Aug 2025 healthcare, pharmaceuticals, fda, regulatory review, patent extension

💊FDA Notice on Patent Extension for IQIRVO Drug Review Period

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IQIRVO 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 26 Aug 2025 business compliance, pharmaceuticals, fda, regulatory review, patent extension, nemolizumab

💊FDA's Regulatory Review Notice for NEMLUVIO Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEMLUVIO 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 1 Aug 2025 international trade, regulatory review, antidumping duties, south korea, u.s. market, polyethylene terephthalate

📦Review of Antidumping Duty Order on PET Sheet from South Korea

The Commission hereby gives notice that it has instituted a review pursuant to the Tariff Act of 1930 ("the Act"), as amended, to determine whether revocation of the antidumping duty order on polyethylene terephthalate sheet from South Korea would be likely to lead to continuation or recurrence of material injury. Pursuant to the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission.

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Notice 25 Jul 2025 business compliance, regulatory review, immigration, uscis, legal services

📝USCIS Notice on Entry of Appearance Revision

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

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Proposed Rule 25 Jul 2025 regulatory review, economic growth, community reinvestment act, capital requirements, banking operations

📉Regulatory Review Overview for Banking Operations and Capital Requirements

Pursuant to the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (EGRPRA), the OCC, Board, and FDIC (collectively, the agencies) are reviewing agency regulations to identify outdated or otherwise unnecessary regulatory requirements on insured depository institutions and their holding companies. Since February 2024, the agencies published three Federal Register documents requesting comment on multiple categories of regulations. This fourth Federal Register document requests comment on the final three categories of regulations: Banking Operations, Capital, and the Community Reinvestment Act, and agency rules issued in final form as of July 25, 2025, including those covered by the three prior documents.

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Notice 14 Jul 2025 business compliance, pharmaceuticals, fda, regulatory review, patent extension

💊FDA Notice on Regulatory Review Period for ABRYSVO Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ABRYSVO 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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