Notice 14 Mar 2025 regulatory compliance, pharmaceuticals, fda, health, drug approval

💊FDA Withdraws Approval of Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of four abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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Notice 14 Mar 2025 endangered species, regulatory compliance, marine mammals, noaa, commercial fishing, mmpa

🐋Proposed Permit for Incidental Take of Endangered Marine Mammals

NMFS is proposing to issue a permit to authorize the incidental, but not intentional, take of specific Endangered Species Act (ESA)-listed marine mammal species or stocks under the Marine Mammal Protection Act (MMPA), in the Category II California (CA) thresher shark/swordfish drift gillnet (>=14 inch (in) mesh) fishery and the corresponding high seas component of the fishery as defined on the MMPA List of Fisheries as the Pacific highly migratory species drift gillnet fishery (hereinafter, collectively referred to as the CA thresher shark/swordfish drift gillnet (>=14 in mesh)/Pacific highly migratory species drift gillnet fishery.

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Proposed Rule 14 Mar 2025 regulatory compliance, aviation, faa, safety, aircraft, aviation safety, incorporation by reference, air transportation, airworthiness directive, boeing, operational safety

✈️Proposed Airworthiness Directive for Boeing 787 Airplanes

The FAA proposes to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8, 787-9, and 787-10 airplanes. This proposed AD was prompted by reports of multiple nonconformances, including excessive gaps and pull-up, found during the assembly and installation of the forward pressure bulkhead. This proposed AD would require an internal and external detailed inspection (DET) of the forward pressure bulkhead (FPB) for any damage and performing applicable on-condition actions. The FAA is proposing this AD to address the unsafe condition on these products.

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Notice 14 Mar 2025 regulatory compliance, public meeting, noaa, south atlantic, fishery management

🎣South Atlantic Fishery Management Council Meeting Notice

The South Atlantic Fishery Management Council (Council) will host a meeting of the Mackerel Cobia Advisory Panel on March 31 and April 1, 2025.

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Notice 14 Mar 2025 regulatory compliance, public meeting, fisheries, fishing industry, noaa, pacific council

🎣Pacific Fishery Management Council Public Meeting Overview

The Pacific Fishery Management Council (Pacific Council) will provide a briefing on preliminary research and data needs to interested Pacific Council members, advisory body members, and the public.

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Notice 14 Mar 2025 regulatory compliance, health care, fda, debarment, drug applications

⚖️FDA Denies Hearing and Issues Permanent Debarment for Garmendia

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Bernardo Garmendia, also known as Bernardo Germendia, (Garmendia) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Garmendia from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Garmendia was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. FDA provided notice to Garmendia of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Garmendia submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.

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Proposed Rule 14 Mar 2025 regulatory compliance, banking, financial institutions, fdic, corporate governance

🏦FDIC Withdraws Proposed Banking Regulations Affecting Corporations

The Federal Deposit Insurance Corporation (FDIC) is withdrawing notices of proposed rulemaking relating to brokered deposit restrictions, corporate governance and risk management, and the Change in Bank Control Act. If the FDIC decides to pursue future regulatory action in any of these areas, it will issue a new proposed rule.

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Notice 14 Mar 2025 regulatory compliance, energy, california, environmental assessment, hydroelectric

🌊Notice of Environmental Assessment for Hydro Project by DOE

The Department of Energy has released an Environmental Assessment concerning the Santa Felicia Hydroelectric Project in Ventura County, California. The assessment evaluates potential environmental impacts of proposed safety improvements at the Santa Felicia Dam, concluding that the actions would not significantly affect the human environment. Public comments are welcomed until April 7, 2025.

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Notice 14 Mar 2025 regulatory compliance, energy, natural gas, ferc, intervention, protest

🔧El Paso Natural Gas Company Regulatory Request and Public Participation Notice

The Department of Energy issued a notice pertaining to El Paso Natural Gas Company's request for authorization to abandon a compressor station. The notice details the process for public participation, including the deadlines for protests and interventions, ensuring stakeholders can address their concerns regarding the proposed project.

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Notice 14 Mar 2025 regulatory compliance, securities, nyse, business operations, port fees

💼Proposed Increase in NYSE Arca Port Fees and Compliance Notice

The SEC has published a notice regarding a proposed rule change by NYSE Arca to amend its fee schedule, increasing port fees and removing the open outcry port fee discount. This change is set to take effect immediately and invites public comments on its potential impacts.

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