News & Analysis as of

Discussion Draft

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

by Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Financial assurance reform – new surety types

by DLA Piper on

The Queensland Government has released its latest discussion paper as part of the broader review being conducted of Queensland's financial assurance framework (read about the other discussion papers here). Financial...more

Bill reforming financial adviser regime introduced to Parliament

by DLA Piper on

The financial services industry has been waiting with bated breath (given the upcoming General Election) for the introduction of the Financial Services Legislation Amendment Bill (Bill), which was introduced to Parliament on...more

Update on Canada's environmental and regulatory review process

by Dentons on

On June 29, 2017, the Government of Canada released its environmental and regulatory reviews discussion paper (Discussion Paper). The Discussion Paper follows from reports prepared by expert panels tasked with reviewing...more

Financial Services Quarterly Report - Second Quarter 2017: Increasing Focus on European ETFs

by Dechert LLP on

The rise of passive investment strategies and the growing momentum of investment in exchange-traded funds (ETFs) has not gone unnoticed by European regulators. The Central Bank of Ireland (Central Bank) recently released a...more

Financial Conduct Authority Publishes Discussion Paper on Distributed Ledger Technology

by Shearman & Sterling LLP on

The Financial Conduct Authority has published a discussion paper on distributed ledger technology (DLT). The FCA is seeking to start a dialogue on the potential for future development of DLT in the markets it regulates. The...more

FCA Launches Discussion on Distributed Ledger Technology

by Latham & Watkins LLP on

UK regulator calls for submissions on potential uses, risks and benefits of distributed ledger technology in the financial services sector. The Financial Conduct Authority (FCA) published a Discussion Paper (DP17/3) on...more

Blockchain: UK regulator asks for input as it addresses emerging business models

by DLA Piper on

A Financial Conduct Authority (FCA) discussion paper is seeking views by July 17 on the potential for future development of distributed ledger technology (DLT) in the markets it regulates. The paper does not expressly define...more

Financial Conduct Authority: primary markets review

by Dentons on

The Financial Conduct Authority (FCA) has published two papers as part of its review of the structure of the UK's primary markets to ensure that they continue to serve the needs of issuers and investors....more

FDA Hits “Pause” on Regulation of LDTs

by Foley & Lardner LLP on

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that,...more

US Federal Reserve Board Releases Discussion Paper on Distributed Ledger Technology

by Shearman & Sterling LLP on

In early December 2016, the US Federal Reserve Board’s Divisions of Research & Statistics and Monetary Affairs released a discussion paper entitled “Distributed Ledger Technology in Payments, Clearing, and Settlement.”...more

A Work in Progress: The Legal Function and the FCA's Senior Managers' Regime

by WilmerHale on

The Senior Managers and Certification Regime (the “Regime”) came into force on 7 March 2016, with the stated aim of enhancing and embedding a culture of individual responsibility and accountability within the UK’s banking...more

Innovation in the Securities Markets: ESMA Releases Discussion Paper on Distributed Ledger Technologies

by Ropes & Gray LLP on

The European Securities and Markets Authority (“ESMA”) published today a Discussion Paper on the application of “distributed ledger technologies” (“DLT”) to securities markets. This technology derives from the virtual...more

European Banking Authority Consults on LCR Disclosure and Disclosure of Liquidity Risk Management

by Shearman & Sterling LLP on

The European Banking Authority published a consultation paper on draft guidelines on liquidity coverage ratio disclosures, to complement the disclosure requirements of liquidity risk management under the Capital Requirements...more

Bypassing Encryption Under Court Orders: New Bill Scares the Privacy Community

by McGuireWoods LLP on

Senators Diane Feinstein and Richard Burr have released a discussion draft on providing technical assistance to law enforcement seeking to gain access to encrypted information pursuant to a court order. The draft has been...more

ESMA Publishes Discussion Paper on European Benchmarks Regulation

On February 15, the European Securities and Markets Authority (ESMA) published a discussion paper (ESMA/2016/288) (Discussion Paper) regarding implementation of the regulation on indices used as benchmarks in financial...more

FCA consults on IFISA changes

by Dentons on

FCA has published a discussion paper on the updates it plans to make to its rules and guidance on disclosure and advice relating to loan-based crowdfunding investments (peer to peer (P2P) agreements) in response to the...more

Proposed CEQA Guidelines Amendments: A Critique of OPR’s “Preliminary Discussion Draft” (Part II – Proposed “Substance” and Major...

by Miller Starr Regalia on

On September 18, 2015, I posted a “Part I” piece on the “efficiency improvements” category of OPR’s Preliminary Discussion Draft of its “Proposed Updates to the CEQA Guidelines” (the “Discussion Draft”). This follow up post...more

CEQA Guidelines Comments: Once In a Generation Chance

by Beveridge & Diamond PC on

The California Environmental Quality Act (CEQA) directs that certain proposed projects undergo environmental review to assess and mitigate significant environmental impacts. The CEQA Guidelines provide procedures and...more

ESMA Publishes Discussion Paper on EMIR Standards Relating to CCP Client Accounts

On August 27, the European Securities and Markets Authority (ESMA) published a discussion paper (Discussion Paper) on the review of Article 26 of ESMA’s Regulatory Technical Standards (153/2013) (RTS) under the European...more

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

by McGuireWoods LLP on

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

by Ropes & Gray LLP on

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

TSCA Reform: Detailed Review of the TSCA Modernization Act of 2015 Considered in Markup by the House Energy and Commerce Committee

by Bergeson & Campbell, P.C. on

The House Energy and Commerce Committee convened a markup session on June 2 and 3, 2015, to consider a slightly revised version of the TSCA Modernization Act of 2015 as H.R. 2576. As reported in our June 3, 2015, memorandum,...more

Senator Shelby Speaks to Baker Donelson; Releases Financial Regulatory Proposal

by Baker Donelson on

U.S. Senator Richard Shelby (R-Alabama), chairman of the United States Senate Committee on Banking, Housing, and Urban Affairs, last week released the text of the discussion draft of "The Financial Regulatory Improvement Act...more

TSCA Reform: Detailed Review of Representative Shimkus' Second Discussion Draft of TSCA Reform Legislation

by Bergeson & Campbell, P.C. on

On May 12, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a new (second) draft of the TSCA Modernization Act of 2015 (TMA2 DD). In April,...more

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Cybersecurity

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