News & Analysis as of

Regulatory Standards

Taking Security Guide

by Dentons on

In our interconnected global economy, banking and finance transactions are becoming increasingly complex and regulatory frameworks are constantly evolving. The act of taking security, that is, the creation and enforcement of...more

An Insider’s Look at California’s New Gender Identity Regulations: Restroom Access, Pronoun Preference, and More

Regulations drafted by California's Fair Employment and Housing Council addressing issues related to gender identity will become effective July 1, 2017. These first-of-their-kind California regulations will seek to do what...more

Real Estate Investment in Africa: Is the Honeymoon Over?

by DLA Piper on

The environment for real estate investment in Africa contains a perplexing mix of positive and negative factors. This is quite apart from the obvious fact that, in a continent of 54 countries and wide variations in levels...more

CEQA Review of Cannabis Regulations - Comment Period Opens on Draft Program Environmental Impact Report of MCRSA and AUMA

by Best Best & Krieger LLP on

The California Department of Food and Agriculture recently released its CalCannabis Cultivation Licensing Draft Program Environmental Impact Report. The intent of the PEIR is to conduct environmental review of the regulations...more

Obama Administration’s Organic Animal Welfare Rule Postponed a Second Time

by Varnum LLP on

For the second time, the effective date of the Organic Animal Welfare Rule (OAWR) proposed by the United States Department of Agriculture during the last days of the Obama administration has been pushed back. The new...more

How Life Sciences and Pharmaceutical Companies Can Harness Opportunity in Their Supply Chains

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells counsel Penny Powell talks about disruptive technologies, the increasing trend towards collaboration and joint venture agreements, the opportunities and regulatory burdens...more

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

by Hogan Lovells on

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated...more

The return of the kin liability (Sippenhaft) – Liability of parent companies after the 9th amendment of the German Act against...

by Hogan Lovells on

The Middle Ages are regarded as the golden age of the kin liability (Sippenhaft) in Germany. According to the principle of kin liability, family members had to stand up for the actions of their relatives, regardless of...more

MiFID II for Non-EU Fund Managers

by Shearman & Sterling LLP on

The revised EU Markets in Financial Instruments package—known as MiFID II—takes effect on January 3, 2018. New rules on trading inducements, research, best execution, market transparency and the regulation of algorithmic...more

FDA Steps Up on Medical Device Innovation

by Mark Mansour on

At long last, FDA has the makings of a coherent and forward-thinking policy to address the widening gap between industry's ability to innovate and FDA's regulatory capacity. Consistent with the mandate of the 21st Century...more

China FDA Proposes Hatch-Waxman-Like Regulatory Framework Linking Drug Approval to Patent Rights

Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more

Suniva/SolarWorld Section 201 Solar Panel Proceeding

On May 23, 2017, the U.S. International Trade Commission ("USITC") initiated a proceeding under section 201 of the Trade Act of 1974 to determine if imports of crystalline solar photovoltaic ("CSPV") cells and modules are...more

IoT Cybersecurity and Data Privacy Trends in Asia: Be Ready

by Hogan Lovells on

In this hoganlovells.com interview, Hong Kong-based Hogan Lovells partner Mark Parsons talks about the regulatory environment in Asia as it relates to cybersecurity, data privacy, and the Internet of Things (IoT)....more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

Changes in insurance regulation: China / Hong Kong / Singapore / Indonesia / Vietnam

by Hogan Lovells on

Please find our Asia insurance regulatory tracker for the first quarter of 2017. It includes updates on the new independent insurance regulator for Hong Kong (which will assume its functions on 26 June), new rules on...more

Regulatory Competitiveness of Petrochemical Projects in Alberta

by Bennett Jones LLP on

On June 6, 2017, Brad Gilmour, Head of the Regulatory Department of Bennett Jones, spoke at the Petrochemical Conference organized by the Canadian Energy Resources Institute. As part of the Executive Panel focusing on the...more

Drone Federalism Act, Seeking Regulation of Drones at the Local Level

The Drone Federalism Act of 2017, introduced by U.S. Senators Dianne Feinstein, Mike Lee, Richard Blumenthal, and Tom Cotton, seeks to “establish a process for federal, state, local and tribal governments to work together to...more

Brazil's Developing Gas Marketing: Opportunities for Arbitration

by WilmerHale on

Historically, natural gas did not play a significant role in Brazil’s energy mix, never exceeding 4% of Brazil’s primary energy supply until the late 1990s. Today, natural gas accounts for 12% of Brazil’s primary energy...more

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

by Hogan Lovells on

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that...more

Are We Due for a Makeover?

by Hogan Lovells on

Many have questioned what affect a proposed legislative facelift, to the cosmetic industry, will have on manufacturers, retailers and, of course, on consumers. According to the Department of Trade and Industry, the total...more

Force Maijoor: supervisory convergence - a view of the impact from Italy

by Hogan Lovells on

On 11 April 2017, Steven Maijoor, the Chair of the European Securities and Markets Authority ("ESMA") addressed the potential regulatory issues which may affect EU Member States as a result of the Brexit effect on passporting...more

Insurers to benefit from mutual solvency recognition between Mainland China and Hong Kong

by Hogan Lovells on

On 16 May 2017 the CIRC and the Hong Kong Office of the Commissioner of Insurance (“OCI“) entered into a framework agreement aimed at mutual recognition of solvency regimes between Mainland China and Hong Kong....more

Medical devices – South Africa's changing landscape

by Hogan Lovells on

Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa.  Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices...more

Funds Talk: June 2017 - Incident Response Plans Form an Essential Part of Cybersecurity Frameworks

Cybersecurity has increasingly moved into the spotlight in recent years, with regulators and financial firms alike clambering to keep pace with rapidly changing demands as threats continue to evolve....more

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