News & Analysis as of

Regulatory Standards

U.S. watchdogs tally $1.5 billion cost for one type of defective medical device

Big medical device makers, like Big Pharma, have complained Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents...more

Drone Industry Grows, the Fight for Control of the Sky Builds

It’s now considered ‘cool’ to fly a drone whether you are doing it for your business or as a hobbyist in your own backyard. When the Federal Aviation Administration (FAA) released the final rules for small unmanned aerial...more

Food & Beverage Litigation Update | October 2017 #2

by Shook, Hardy & Bacon L.L.P. on

Chicago Repeals SSB Tax After Two Months of Enforcement - Chicago officials have voted to repeal a sugar-sweetened beverage (SSB) tax approved in November 2016 by the Cook County Board of Commissioners but delayed by a...more

Dieselgate: Bringing a Face to Scandal Impacting Volkswagen Owners

A Volkswagen manager pleaded guilty to conspiracy and violating the Clean Air Act and could get seven years in prison. A Volkswagen engineer who agreed to testify against the Volkswagen manager was sentenced to three years in...more

States Respond to Equifax Cyber Breach with Enforcement Actions and Calls for Enhanced Regulatory Powers

In the wake of last month’s historic cyber breach of Equifax, which resulted in the theft of sensitive personal information belonging to over 140 million Americans, states have wasted no time in seeking a greater role in...more

Shanghai Tightens Industry Interactions with HCPs

by Ropes & Gray LLP on

In August 2017, multiple departments of Shanghai government, led by Shanghai’s Health and Family Planning Commission (“Shanghai HFPC”), jointly issued a series of administrative rules (collectively, “Recent Shanghai Rules”)...more

NAIC Big Data Working Group Update

by Carlton Fields on

Regulators are hard at work considering insurers’ use of big data and analytics. The Big Data (Ex) Working Group, chaired by Oregon Commissioner Laura Cali Robison, adopted three charges for 2017. Briefly, these charges are...more

Health Care E-Note - September 2017

by Burr & Forman on

On June 2, 2017, Anderson, South Carolina-based AnMed Health and the Department of Health and Human Services Office of Inspector General entered into the largest settlement under the Emergency Medical Treatment and Labor Act...more

McDowell v. CGI Federal Inc.: A Stark Reminder to Government Contractors of their Cybersecurity Obligations

by Hogan Lovells on

On June 1, 2017, the United States District Court for the District of Columbia issued a decision in a class action lawsuit, McDowell v. CGI Federal Inc., Civ. Action No. 15-1157 (GK) (D.D.C. 2017), which could have...more

Alberta Releases Proposed Cannabis Framework

by Bennett Jones LLP on

On October 4, the government of Alberta released its proposed framework for legalized recreational cannabis. The framework sets out Alberta’s primary policy goals with respect to the implementation of a recreational cannabis...more

CMMI Requests Ideas to Spur Innovation and Reduce Burden

by Polsinelli on

The Center for Medicare & Medicaid Innovation (CMMI) is seeking ideas on how to better drive change and reduce regulatory burden. CMMI solicited ideas to shape the agency’s future activities through a September 2017 “request...more

Financial Services Quarterly Report - Third Quarter 2017: Hong Kong SFC Issues Clarification on Standards Expected of Asset...

by Dechert LLP on

The Hong Kong Securities and Futures Commission (SFC) recently released a circular outlining its views on how asset managers should address certain conflicts of interest between private funds and separately managed accounts...more

#Ad and the challenges of native advertising and social influencers

by Hogan Lovells on

Westminster Media Forum recently hosted a seminar to discuss native advertising and social influencer marketing and their measurement, regulation and impact on brands....more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

European Commission adopted legal acts to improve Good Manufacturing Practices for medicinal products

by Hogan Lovells on

On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (“GMP”) requirements for investigational and authorised medicinal products in the EU. The purpose of these...more

Steering the course – navigating bribery and corruption risk in private equity investments: Part 1

by Hogan Lovells on

Identifying Bribery and Corruption risk in the context of private equity investments (and M&A more generally) is key to ensuring the value of an acquisition. Companies will busy themselves with due diligence on tax,...more

A road map to life sciences M&A in Spain

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

Fifth Circuit Affirms Contractors Cannot Be Criminally Liable for OCSLA Violations

On September 27, 2017, the Fifth Circuit in U.S.A. v. Don Moss, Curtis Dantin, Grand Isle Shipyard, Incorporated, and Christopher Srubar, No. 16-30516 (5th Cir. September 27, 2017), issued a decision affirming the District...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 6

by Jones Day on

TOP NEWS - FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule - On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce...more

CEQA Compliance for Commercial Cannabis Business Licensing under MAUCRSA - Proposal Open to Comments

by Best Best & Krieger LLP on

The Bureau of Cannabis Control proposes to adopt a Negative Declaration related to its regulatory licensing and enforcement program for commercial cannabis distributors, retailers, testing laboratories, and microbusinesses...more

Medical Board of California Adopts New Regulations for Midwife Assistants

by Nossaman LLP on

On September 21, 2017, the Medical Board of California adopted new regulations related to the training of midwife assistants, the administration of midwife assistant training, and the requirements for approved, midwife...more

State of Florida Provides Additional Guidance on New Generator Obligation for Senior Living Facilities

Florida Argentum has worked with the Florida Agency for Health Care Administration (AHCA) and Florida Department of Elder Affairs (DOEA) to obtain clarification on several matters with respect to Governor Scott’s emergency...more

Industrial Chemicals Bill 2017: Recent Developments - Nearly all ingredients in cosmetic products are regulated as industrial...

by Dentons on

Nearly all ingredients in cosmetic products are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth) (the IC(NA) Act)....more

EMA's reply to the EU Ombudsman inquiry on pre-submission interactions with medicinal product developers

by Hogan Lovells on

The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities....more

Risky Business: Mitigating Exposure Through Comprehensive Risk Management

by Ropes & Gray LLP on

Ropes & Gray is pleased to share “Risky Business,” a comprehensive report on trends and best practices in risk management. Based on a survey by FT Remark, a research service from the Financial Times that interviewed 300...more

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Cybersecurity

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