Regulatory Compliance, Industry Impact 16 Jan 2025 pharmaceuticals, new drug application, fda, drug approval, vanda pharmaceuticals, regulatory compliance

💊FDA Proposes Refusal of TRADIPITANT Drug Application

The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules, 85 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.

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Regulatory Compliance, Industry Standards 16 Jan 2025 business impact, doe, portable electric spas, regulatory compliance, energy conservation

♻️Energy Conservation Standards for Portable Electric Spas Announced

The U.S. Department of Energy ("DOE") is publishing this notice of data availability ("NODA") regarding certain data and analytical results being made available related to DOE's evaluation of potential energy conservation standards for portable electric spas ("PESs").

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Regulatory Requirements, Business Operations 16 Jan 2025 postal service, regulatory compliance, business operations, shipping services

📦Notice of New Priority Mail Services Contract by Postal Service

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Regulatory Compliance, Transportation, Energy Efficiency 16 Jan 2025 csx, federal railroad administration, regulatory compliance, product safety plan, transportation

🚂CSX's Petition for Product Safety Plan

This document provides the public with notice that, on November 11, 2024, CSX Transportation, Inc. (CSX) submitted a petition for FRA approval of its Product Safety Plan (PSP) for the Trip Optimizer Air Brake Control product (also referred to as "TO Air Brake Control" or "Air Brake Control"). As this petition involves a railroad's PSP, FRA is publishing this notice and inviting public comment on the document.

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Regulatory Compliance, Environmental Impact 16 Jan 2025 flood insurance, fema, business implications, regulatory compliance, nelson county

🌊Proposed Flood Hazard Determinations for Nelson County, KY

On July 15, 2024, FEMA published in the Federal Register a proposed flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table to be used in lieu of the erroneous information. The table provided here represents the proposed flood hazard determinations and communities affected for Nelson County, Kentucky and Incorporated Areas.

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Regulatory Requirements, Industry Standards 16 Jan 2025 consumer trends, agriculture, poultry, standards, usda, regulatory compliance

🍗USDA Seeks Comments on Poultry Standards Revisions by 2025

The U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is seeking public comment on revisions to the United States Classes, Standards, and Grades for Poultry (the Poultry Standards). The last minor revision to the Poultry Standards occurred in 2018, but the last substantial revision prior to that occurred in 1998. Since then, poultry production and quality assessment methods have changed significantly, as have consumer preferences.

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Regulatory Compliance, Business Agreements 16 Jan 2025 postal service, business agreements, competitive products, regulatory compliance, shipping

📦USPS Notice on Priority Mail Express & Ground Advantage Changes

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Regulatory Compliance, Business Impact 16 Jan 2025 usps, postal service, shipping agreements, regulatory compliance, priority mail

📦USPS Notice on Product Change for Priority Mail Services in 2025

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Regulatory Compliance, Business Operations 16 Jan 2025 postal service, negotiated service agreements, business logistics, regulatory compliance, shipping

📦USPS Notice on Priority Mail Express and Ground Advantage Changes

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Regulatory Changes, Shipping Services 16 Jan 2025 postal service, negotiation, regulatory compliance, shipping, business strategy

📦Regulatory Notice

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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