News & Analysis as of

Manufacturers

Proposition 65: Three Months until Effective Date for OEHHA’s Amended Proposition 65 Clear and Reasonable Warnings Requirements

by Bergeson & Campbell, P.C. on

There are approximately three months until the effective date of the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings”...more

Following a cyber attack, IoT device manufacturers, data controllers, and sellers could face liability under the EU’s Product...

by Hogan Lovells on

Advancements in technology may provide consumers with a continuous stream of upgraded products, but they’re also proving that current security and privacy regulations fall short within the Internet of Things (IoT)....more

Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug...

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus...more

Game Over: Australian High Court Dismisses Valve's Appeal of Penalty

by Jones Day on

As a result of its dismissal of an appeal from video game publisher Valve in April 2018, the High Court of Australia has affirmed that overseas-based companies that sell to Australia must abide by the Australian Consumer Law...more

Patent Related Changes To Bayh-Dole Act Regulations

by Foley & Lardner LLP on

Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that...more

Congress Continues Push on Medical Device Cybersecurity Mandates - FDA Issues Medical Device Safety Action Plan; DHS Continues to...

by Holland & Knight LLP on

Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The...more

California Proposition 65 Amendments – An Unsavory Impact on Food and Beverage Industries?

by Davis Wright Tremaine LLP on

Now is the time to update your Proposition 65 warnings in California. On August 30, 2018, new regulations go into effect changing the warnings required for the food and beverage industries. Amendments to California’s...more

Supplying Products & Managing Margin Down Under: Online Price Erosion Strategies for Product Manufacturers in Australia and New...

by K&L Gates LLP on

The Australian and New Zealand markets present a dilemma for manufacturers. Both are highly developed economies with wealthy, well-educated consumers who are amongst the world's most enthusiastic adopters of new technologies....more

Fourth Circuit Rules that Maryland’s Anti-Price Gouging Act for Off-Patent or Generic Drugs is Unconstitutional

The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce...more

Trump DOJ’s Antitrust Enforcement Policies Are Predictably Unpredictable

by Holland & Knight LLP on

More than 40 years ago, the Supreme Court determined that efficient enforcement of the Sherman Act required a bright-line rule, with very limited exceptions, barring antitrust claims by "indirect purchasers"—end customers who...more

New Product Safety Requirements and Recall Procedures Adopted in Mexico: Time for Manufacturers to Update their Compliance...

by Foley & Lardner LLP on

The commercial and legal environment on product safety in vehicles, auto parts and other products has substantially changed in Mexico in 2018. Manufacturers carrying out business activities in Mexico should now be...more

Clean Air Act/Applicability Determination Index: U.S. Environmental Protection Agency Publishes Notice of Additions

The United States Environmental Protection Agency (“EPA”) maintains a compendium of written responses to certain Clean air Act inquiries from owners or operators of sources. This compendium is known as an Applicability...more

European Commission Releases First Proposals for Truck CO2 Standards; Truck Industry Reacts

by Foley & Lardner LLP on

On May 17, 2018, the European Commission released a legislative proposal for the first ever CO2 emissions standards for heavy duty vehicles in the European Union. The EU has no current limits on CO2 emissions from heavy duty...more

A Brief Guide to the Replica Motor Vehicle Exemption to Federal Safety Standards in the Face of Implementation Delays

by Buchalter on

Federal Motor Vehicle Safety Standards normally prohibit a person from selling any motor vehicle or motor vehicle equipment that does not comply with federal motor laws, including EPA emissions standards and FMVSS safety...more

Health Care : Helpful Hints – May 2018

by Burr & Forman on

OIG Issues New Advisory Opinion on May 7, 2018 - The Office of Inspector General (“OIG”) approved a proposed arrangement involving medical devices/supplies. OIG Advisory Opinion No. 18-02 concerns an arrangement where a...more

44 African Countries Sign Agreement to Establish African Continental Free Trade Area

by Jones Day on

The Situation: African leaders gathered in Kigali, Rwanda, in March 2018 to sign the draft Agreement Establishing the African Continental Free Trade Area ("CFTA") and other related protocols. Forty-four of the 55 Member...more

3D Printing Quarterly Report - Q1 2018

by Benesch on

African labs build 3D printers from e-waste - Two labs in African nations have built 3D printers out of e-waste. Staff at WoeLab in Togo, a community tech hub and inventor/entrepreneur network, built a 3D printer in 2013...more

Trade Dress Catches Up With Ketchup

On a recent happy hour trip to HopCat, a brewpub chain with an incredible beer list of local and regional craft beers, I expected to find a trademark issue or two among the tap handles.  However, instead, I was distracted by...more

Scrap Separating/Crushing/Grinding Equipment: Institute of Scrap Recycling Industries Comments on China 301 Tariff List

The Institute of Scrap Recycling Industries (“ISRI”) submitted May 11th comments to the Office of the United States Trade Representative (“Office”) in regards to the Administration’s review in consideration of imposing...more

CPSC Recall Snapshot

by Alston & Bird on

Welcome to the May edition of the Alston & Bird CPSC Recall Snapshot. Earlier this month, the CPSC joined its counterparts at the Federal Consumer Protection Agency of Mexico (PROFECO) and Health Canada in attending the...more

Ninth Circuit Brings Clarity To Made In The USA Labeling

by Cozen O'Connor on

Thanks to the California legislature and the Ninth Circuit’s recent unpublished opinion in Fitzpatrick v. Tyson Foods, food manufacturers and distributors in California can label their products “Made in the USA,” even if the...more

Cooperative Success in Changing the Autonomous Vehicle Legal Landscape

Rumors flew as early as 2016 that Kitty Hawk, a three-year-old corporation backed by Google co-founder Larry Page, had entered the autonomous aerial vehicle space. This March, the world learned that the mysterious flying...more

State + Local Tax Insights: Spring Issue 2018

by Morrison & Foerster LLP on

CONTRACT MANUFACTURING AND MASSACHUSETTS: OUT-OF-STATE BUSINESSES BEWARE - In Massachusetts, the concept of manufacturing has evolved. Smoke stacks and assembly lines, once common in the Commonwealth, continue to...more

Under the Hood of Liability in the Age of Self-Driving Vehicles

Self-driving cars and related legal issues have captivated the cybersecurity world as of late. And with good reason. In 2018 we saw the first fatality associated with a self-driving Uber, adding to the growing attention paid...more

Pentagon Bans Sale Of Huawei And ZTE Phones To Military Personnel

by King & Spalding on

The Department of Defense has ordered retail stores on U.S. military bases to stop selling phones made by two Chinese manufacturers, Huawei Technologies Co. and ZTE Corp. The move signals an escalating view from the U.S....more

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Cybersecurity

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