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Manufacturers

UK Publishes Draft Legislation Prohibiting the Manufacture and Supply of Cosmetic Products Containing Microbeads

by Hogan Lovells on

On 11 September 2017, the UK Department for Environment, Food and Rural Affairs (DEFRA) published draft regulations prohibiting the manufacture and supply of rinse-off personal care products containing microbeads. The draft...more

Africa Stand Up Vision 2025: Strengthening supply chains – the key challenge for Africa

by Hogan Lovells on

If Africa wants to change how it trades with the rest of the world, it needs to start by rethinking how it trades with itself. Without urgent improvement, Africa risks remaining a supplier of solely primary materials to which...more

Blog: California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products

by Cooley LLP on

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers...more

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

by Stinson Leonard Street on

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

Hurricanes Force Manufacturers to Consider Impact on Employees

Hurricanes Harvey and Irma caused widespread property damage and flooding, and some manufacturers may not be able to reopen their businesses for several months. To assist followers of this blog, I have set out below a few of...more

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation, and Other Recent REACH Developments

by Bergeson & Campbell, P.C. on

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation: In July, the European Chemical Industry Council (Cefic) provided comments in response to the European Commission’s (EC) “Stakeholder Consultation...more

The United States Munitions List: When Guns Come Off of the ITAR

In our blog shop, most of the news we scan is the nerdy minutia of regulatory nuance. But the other day, we found big news, a real scoop. The ITAR will be rewritten to remove guns and ammunition from its control....more

New Jersey Joins Wave of States Proposing New Rules for Drug Marketing and HCP Interactions

by Hogan Lovells on

Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more

The life sciences industry under the antitrust spotlight in China: two practical points

by Hogan Lovells on

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

FDA Clarifies Trading Partners Under the DSCSA

by Reed Smith on

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with...more

Supply Chain Problems After The Hurricanes: What Manufacturers Should Be Aware Of

As the recovery effort continues after Hurricane Harvey and Hurricane Irma, some manufacturers are starting to deal with supply chain slowdowns or shortages. The most widely reported issue that impacts both manufacturers and...more

Missouri Adopts High Burden for Venue Challenges and Affirms a $23 Million Punitive Damages Award Based, in Part, on a...

by Lathrop Gage on

On September 12, 2017 the Missouri Supreme Court handed down its 4-3 opinion in Barron v. Abbott Laboratories, Inc., SC96151, dealing a significant blow to businesses who seek to transfer cases from Missouri trial venues...more

ITC Prepares to Vote on the Suniva/SolarWorld proceeding re Crystalline Silicon Photovoltaic Cells

by Stoel Rives LLP on

As we approach the critical September 22 vote of the U.S. International Trade Commission (ITC) for the U.S. solar industry, here is a brief review of how we arrived at this point and what to expect. This vote will...more

U.S. Environmental Protection Agency Office of Inspector General Project Notification: Evaluation of Importers' and Manufacturers'...

The United States Environmental Protection Agency (“EPA”) has issued an August 22nd Project Notification titled: Evaluation of Importers’ and Manufacturers’ Chemical Data Reporting Under the Toxic Substance Control...more

FDA Finalizes Guidance on Interoperable Medical Devices

by McGuireWoods LLP on

Recently, the U.S. Food and Drug Administration (FDA) finalized guidance summarizing its recommendations for interoperable medical devices, or devices that are connected to each other and to other technology. Noting the...more

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

Intel Ruling: General Court Failed to Examine All of Intel’s Arguments, Court of Justice Says

On September 6, 2017, the Court of Justice of the European Union (CJEU) quashed the 2014 judgment of the General Court (GC) that upheld a fine of €1.06 billion ($1.5 billion) on Intel Corporation Inc. (Intel) for abusing a...more

EU Court Orders New Assessment of Intel's Rebates

by Dechert LLP on

The Court of Justice of the European Union (CJEU) has quashed a ruling by the EU’s General Court which had upheld the European Commission’s (EC) 2009 finding of abuse of dominance by Intel Corporation Inc. Intel was fined...more

New era dawning in EU competition law? CJEU endorses an effects-based assessment of rebates and sets aside lower court’s judgment...

by White & Case LLP on

Intel and the effects-based approach in EU competition law - On 6 September 2017, the Court of Justice of the European Union ("CJEU" or "Court") essentially held in Intel1 that the European Commission ("Commission") cannot...more

Talcum Plaintiffs Can’t Show Personal Jurisdiction In Show Me State

by Reed Smith on

“I am from Missouri. You have got to show me.” That quote attributed to Congressman Willard Duncan Vandiver in 1899 is reputedly the source of Missouri’s unofficial nickname, the “Show Me” state. Or maybe it isn’t. Whatever...more

Wisconsin High Court Affirms High Summary Judgment Bar to Trade Secret Misappropriation Claims

by Seyfarth Shaw LLP on

A recent decision from the Supreme Court of Wisconsin affirmed a trial court’s grant of summary judgment in favor of a defendant accused of conspiring to misappropriate its competitor’s trade secrets. By a 4-3 decision in...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

WARNING! Prop 65 regulations are a year away in California. Is Your Product’s Warning Label Compliant?

by Wilson Elser on

After many years of debate, consideration and public input, California’s new regulations go into effect on August 30, 2018, under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 - commonly known as Prop 65....more

NAFTA Watch Newsletter Vol. 7 - NAFTA Renegotiation Part 1: A Tense Start, Then Progress

by Benesch on

This publication is our seventh installment in a series designed to provide our clients in the manufacturing, transportation and logistics, and related industries with monthly updates on any action taken by the Trump...more

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