💊FDA Determines SYNDROS Not Withdrawn, Opens Doors for Generics
The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met.
Learn More🌍Impact of NEPA Procedures Rescission on Business and Compliance
This interim final rule rescinds DON's regulations implementing the National Environmental Policy Act (NEPA), because the Council on Environmental Quality's (CEQ) NEPA regulations, which they were meant to supplement, have been rescinded, and because the DoD is promulgating Department-wide NEPA procedures that will guide the Navy's NEPA process. In addition, this interim final rule requests comments on this action.
Learn More🚗NHTSA Notice on Information Collection Activities for Automotive Safety
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval.
Learn More🏦FDIC Reinstates Prior Bank Merger Policy for Clarity and Compliance
The FDIC is taking final action to rescind the Statement of Policy on Bank Merger Transactions published in 2024 (2024 Statement of Policy) and reinstate its Statement of Policy on Bank Merger Transactions that was in effect prior to the 2024 Statement of Policy (Bank Merger Statement of Policy). The reinstated Bank Merger Statement of Policy will remain in effect pending the FDIC's review of all aspects of the regulatory framework governing the FDIC's review of merger transactions in connection with a future proposal to comprehensively revise its merger policy.
Learn More💹SEC Regulatory Notice on Osprey Bitcoin Trust Trading Proposal
The SEC has initiated proceedings to evaluate a proposed rule change by Cboe BZX Exchange for listing and trading shares of the Osprey Bitcoin Trust. This involves assessing the proposed Trust's compliance with existing regulations and soliciting public comments to inform the decision-making process. Stakeholders are encouraged to provide written feedback regarding potential issues and the implications of this proposal on market integrity.
Learn More📋CMS Notice on Proposed Information Collection Activities
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More📄FDA Information Collection Activities and Approvals Summary
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More📈Nasdaq Proposes Rule Change for 21Shares Dogecoin ETF Trading
The Securities and Exchange Commission has extended the review period for Nasdaq's proposed rule change to list and trade shares of the 21Shares Dogecoin ETF. This decision allows for further consideration of the proposal and reflects the ongoing evolution in cryptocurrency investment within regulated markets, highlighting industry interest in innovative financial products.
Learn More🧪FDA Notice
The Food and Drug Administration (FDA or Agency) 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 information collection associated with implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Learn More📈Proposed NYSE Rule Changes on Trading Halts Impact Businesses
The New York Stock Exchange (NYSE) filed proposed rule changes to amend its regulations on trading halts, intending to merge existing rules for clarity and consistency across self-regulatory organizations. The changes aim to enhance regulatory oversight for trading activities in response to operational or regulatory disruptions, thus promoting orderly market conditions.
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