Manufacturers

News & Analysis as of

California May Collect Certain Information from Businesses to Support Its New Proposition 65 Website

California’s Office of Environmental Health Hazard Assessment (OEHHA) has launched a website, www.P65Warnings.ca.gov, intended to provide both businesses and consumers with information regarding the requirements for...more

The Toxic Substances Control Act Overhaul: What You Need to Know

On June 22, 2016, President Obama signed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” into law, making comprehensive changes to the Toxic Substances Control Act (TSCA). This step comes after years of...more

New Weapon For Manufacturers: Defend Trade Secrets Act of 2016

On May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic...more

Toxic Substances Control Act Overhauled Chemical Risk Regulation in the U.S. Joins the 21st Century

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act). Passed with significant bipartisan support, the Act is the first major update to a federal...more

President Signs TSCA Legislation Modernizing Nation’s Chemical Safety Program

On June 22, 2016, the President signed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” a landmark law containing major reforms to the Toxic Substances Control Act (“TSCA”). As noted in Balch &...more

Online Sales Restrictions Remain a Hot Topic: UK CMA Issues Statement of Objections

On 9 June 2016, the UK’s Competition and Markets Authority (CMA) issued a statement of objections (SO) to Ping Europe Limited (Ping), a golf equipment manufacturer, alleging that Ping had breached EU and UK competition law by...more

Implications of New Lautenberg Act’s Sweeping Changes to Toxic Substances Control Act

President Obama signed HR 2576, the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), into law on June 22, 2016. The Lautenberg Act makes significant changes to the Toxic Substances Control Act...more

The UK has voted to leave the EU: What now?

The British public have voted that the UK should leave the EU. The EU Referendum vote (the Leave Vote) does not by itself result in an automatic UK exit from the EU. The EU Treaty provides for a framework for a “Brexit”...more

Picture of Health: FDA Rule Allows Symbols to Replace Text on Device Labels

In June 2016, the U.S. Food and Drug Administration (FDA) issued its final rule explicitly allowing the use of approved symbols, without accompanying text, on medical device and certain biological product labeling. The FDA...more

FAA’s New Rules for Small Unmanned Aircraft

Since the Federal Aviation Administration issued its proposed rules for small Unmanned Aircraft Systems (UAS) in February of 2015, the industry has been eagerly waiting to learn what the final rules will be. On Tuesday, June...more

Like Dominoes: Vermont Follows New Hampshire’s Lead and Makes Drastic Changes to Its Equipment Dealer Statute

In a dealer-friendly move that is growing increasingly common, see here, Vermont recently made substantial changes to the law that governs the relationship between equipment manufacturers and dealers within the state. Much...more

President Obama Signs Major Overhaul of TSCA Changing the Way The EPA Regulates Toxic Substances In Commerce

President Obama just signed a bill amending the Toxic Substances Control Act (“TSCA”), changing the way the EPA regulates chemicals. For the last 25 years, the EPA has regarded TSCA’s principal control provision as unworkable...more

Understanding the Re-Vamped TSCA: Federal Preemption Gives Uniform Standards

The reformed Toxic Substances Control Act (TSCA) is the first major environmental law passed since 1990. President Barack Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) into law on...more

Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two...more

Federal Toxics Law Grows Up: Congress Strengthens the Toxic Substances Control Act

OVERVIEW - President Obama has signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA) for the first time since it was enacted in 1976. The compromise...more

Impact of Brexit for Intellectual Property Rights

A British vote to leave the European Union (EU)—the Brexit referendum issue scheduled for a vote June 23, 2016 — would have a significant effect on intellectual property right-holders, such as manufacturers doing business in...more

Fair Competition Review System

On June 14, 2016, the State Council issued Opinions on Establishing the Fair Competition Review System in the Development of Market System (hereinafter “Opinions”), which finally uncovers the veil of this system....more

Connecticut's New "Right to Try" Law Provides Hope for Patients and Providers, but FDA Remains in the Driver's Seat

Connecticut has recently joined the wave of states enacting a so-called “Right to Try” law, which ostensibly permits terminally ill patients access to investigational drugs (including biologics) and medical devices as a...more

Amendments Strengthen Toxic Substances Control Act

President Obama's signing of amendments to the Toxic Substances Control Law sealed a welcome effort to overhaul the 40-year-old Toxic Substances Control Act (TSCA). The amendments were spurred on by a rare bipartisan...more

California Supreme Court Adopts the Sophisticated Intermediary Defense

In Webb v. Special Elec. Co., the California Supreme Court formally adopted the "sophisticated intermediary doctrine," which provides an additional defense that manufacturers and suppliers can assert against product liability...more

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

On June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized medical device data from device manufacturers...more

Texas Supreme Court Rules Oil and Gas Producer Not Entitled to Sales Tax “Manufacturing Exemption”

On June 17, 2016, the Texas Supreme Court ruled that an oil and gas producer (“Southwest”) was not entitled to a statutory exemption from sales taxes on its purchases of casing, tubing and pumps used in the production of oil...more

When Do "Made in USA" Claims Spark the FTC's Attention?

The Federal Trade Commission (FTC) is tasked with preventing deception and unfairness in the marketplace, including with respect to advertising. One type of deception that the FTC targets involves false claims in advertising...more

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

Vermont to Require Drug Transparency

Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the cost of the drug will come from the state Medicaid program. The Department of...more

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