Tag: Finalizes
DOL Finalizes Plans for Fiduciary-Only Regime
Today, the U.S. Department of Labor released the final version of its “Retirement Security Rule.” After initial review of the fiduciary rulemaking package as detailed in the Fact Sheet, it appears that the Department failed to make any substantive or meaningful improvements to the proposed rule despite significant, specific and data-supported feedback from industry stakeholders. As a result, financial services professionals face a new regulatory regime that imposes a blanket fiduciary threshold for recommending an annuity in a rollover transaction. Moreover, the DOL has largely left intact a constrained and practically unworkable PTE 84-24, a prohibited transaction exemption that has ... Read more
Japan – MHI Finalizes Terms of First Transition Bond Issuance
Mitsubishi Heavy Industries, Ltd. (MHI) has finalized the issuance terms of the transition bond being issued today via public offering in the domestic market, as announced in the Company’s press release of August 5, 2022. The issuance is based on MHI’s selection as a model example for the “2021 Climate Transition Finance Model Projects”* being supported by the Ministry of Economy, Trade and Industry (METI), as announced in the Company’s press release of March 18, 2022. One of the unique features of this model example is that MHI not only plans to achieve emission reductions from its own economic activities, ... Read more
FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products
The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonization of requirements for drug lifecycle management, manufacturers and the FDA can meet these goals in less time through effective management of postapproval changes. To help provide a more predictable and efficient approach to management of postapproval changes, today were announcing a final guidance for industry with new International Council for Harmonisation (ICH) guidelines. Effective implementation of this guidance will provide an opportunity for the FDA to focus ... Read more