Manufacturers

News & Analysis as of

Prop. 65 Conference Focuses on Compliance With New Warning and Settlement Regulations

The Prop. 65 Clearinghouse held its annual conference in San Francisco recently, and the speakers and panelists had a number of recommendations for both retailers and manufacturers following the adoption of Proposition 65’s...more

Interim Regulations Issued on Investigations of Evasion of Anti-Dumping and Countervailing Duties

The anti-dumping (AD) and countervailing duty (CVD) laws provide companies that manufacture products in the United States with a remedy for the injury caused by imports of products that are dumped (i.e., sold at unfairly low...more

Is your cybersecurity upgrade FDA reportable?

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

FDA Drops 19 Ingredients From the OTC Antibacterial Monograph: Antibacterial and Hand Soap Manufacturers Have One Year to Comply.

On September 6, 2016, the Food and Drug Administration (FDA) published a final rule on the use of certain active ingredients which were proposed for inclusion in the Over-The-Counter (OTC) Consumer antiseptic washes portion...more

3 Rounds to Lucas Mill in Chinese Patent Case

In 2014 Lucas Mill discovered a knockoff of its patented portable sawmill being sold online and took immediate action for infringement of its Chinese patent against the Chinese manufacturer, Shandong Shuanghuan Machinery...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Colorado Supreme Court Limits Jurisdiction Over Manufacturers

The Colorado Supreme Court has joined a number of other federal and state courts in limiting the extent to which product manufacturers can be subjected to a state’s general personal jurisdiction, even when the manufacturer's...more

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

E-Commerce: The European Commission Completes Its Preliminary Report on the E-Commerce Sector Inquiry

In May 2015, the European Commission (the Commission) launched a sector inquiry in the field of e-commerce in the context of its Digital Single Market strategy. Its aim was to obtain an overview of prevailing market trends,...more

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

New Proposition 65 Regulation Amendments Modify Clear and Reasonable Warning Requirements and Private Enforcement Settlement...

The California Office of Environmental Health Hazard Assessment (OEHHA) and the California Attorney General each adopted regulatory amendments to the Proposition 65 regulations at the close of August 2016. The OEHHA...more

Time Running Out for Compliance with New DOL Overtime Regulation

As noted in this space in May, effective December 1, employees earning less than $47,476 per year may no longer be treated as exempt from overtime under the federal Fair Labor Standards Act. See “New Wage and Hour...more

Preliminary Report on the E-commerce Sector Inquiry: Key findings

On 15 September 2016, the European Commission published its Preliminary Report on the E-commerce Sector Inquiry. Although the Report is preliminary, its findings already highlight concerns on the part of the European...more

Battery Problems Spread to Smartphones

After more than a decade of laptop battery fires, coupled with the surge in new battery operated devices causing fires (including hoverboards and e-cigarettes), it seemed almost impossible that news of a new string of...more

WARNING: OEHHA amends California Proposition 65 requirements for "clear and reasonable warnings": next steps

The California Office of Environmental Health Hazard Assessment (OEHHA) has introduced the final amendments to the "clear and reasonable warnings" required by Proposition 65. This unique California law, in relevant part,...more

Key Considerations For Foreign Manufacturers That Wish To Sell Products In The United States

Last week, I had the privilege of speaking at the American Bar Association’s Business Law Section Annual Meeting in Boston.  The title of my presentation was:  “Key Considerations for Foreign Manufacturers That Wish to Sell...more

The First Baby Bed: A Guide to Current and Proposed Regulations of Bassinets

Have you ever wondered which type of children's product has the longest history? As far as children's sleeping products are concerned, the bassinet is probably the most time-honored staple. Iron baby beds were developed in...more

The Impact of 3D Printing on Intellectual Property Rights

The term 3D printing encompasses a number of different additive manufacturing methods that enable the production of physical objects without the need for any specific tooling. 3D printing has, for many years, been forecast as...more

GAO, OIG Issue Reports on Medicare Part B Drug Payment Issues

The HHS Office of Inspector General (OIG) and the Government Accountability Office (GAO) recently issued several reports on various Medicare Part B drug reimbursement issues. In a report entitled “Medicare Part B: Data on...more

Under the Dome: Inside the Maine State House

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Community Health Options to Focus on Maine by Leaving New Hampshire In 2017, New Hampshire...more

District Court Grants Permanent Injunction, but Denies Product Recall

A judge in the Western District of Michigan enjoined a roofing manufacturer’s infringing and directly-competing vented soffit product, but denied the patentee’s request for a complete product recall....more

FDA Call For Comments on Off-Label Communications

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

Update: Fundamental Change to U.S. Warranty Law: Consumer Warranties Can Soon be Posted Online

Recent changes to the federal statute governing warranties on consumer products will make it easier and more cost-effective for consumer product manufacturers and suppliers to satisfy the federally-mandated warranty...more

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to...more

California Adopts New "Clear and Reasonable Warning Requirements" for Proposition 65

If you're modifying packaging or introducing a new product, it may be a good time to update your Proposition 65 warnings. On August 30, 2016, California’s Office of Administrative Law approved the adoption of amendments to...more

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