News & Analysis as of

Manufacturers

EPA Issues Direct Final SNURs for Carbon Nanotube (Generic) and Nanocarbon (Generic)

by Bergeson & Campbell, P.C. on

The U.S. Environmental Protection Agency (EPA) promulgated on September 21, 2017, significant new use rules (SNUR) for 37 chemical substances that were the subject of premanufacture notices (PMN). Six of the chemical...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Illinois Attorney General Will Not Seek Reelection in 2018; Democrats Scott Drury and Kwame Raoul Announce Bid for Seat- Illinois AG Lisa Madigan, a Democrat, announced on her campaign website that she will...more

Stout Issues Third Annual Warranty and Recall Report

by Foley & Lardner LLP on

Massive automotive recalls continue to grab headlines and raise concerns industry-wide. Recalls of light vehicles topped 50 million units in 2016, representing the third consecutive year of elevated – and record setting –...more

Netherlands Adopts US FDA-based UDI System for Medical Devices

by Knobbe Martens on

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and...more

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

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