News & Analysis as of

Manufacturers

Tax Law Changes in Saudi Arabia

by Jones Day on

On June 11, 2017, the Saudi Arabian Excise Tax Law ("Excise Tax Law"), as enacted by Royal Decree No. M/86 and dated 27/8/1438 H / May 23, 2017, came into force in Saudi Arabia. The new law implements the GCC Unified...more

Continuous Manufacturing of Pharmaceuticals: FDA Wants to Hear from Industry

by Hogan Lovells on

Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the Agency is still wrapping its head around. Accordingly, on June 22, 2017, FDA...more

China Increases Focus on Electronic Waste

by Latham & Watkins LLP on

As a world leader in the manufacturing of electronic devices, China is beginning to reform its rules and regulations to ensure that the resulting framework is able to keep pace with the rapid developments now taking place in...more

Eastern District of Wisconsin Grants Summary Judgment on Hip Component Manufacturer’s Negligence Claims But Denies Summary...

by Reed Smith on

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.” All of our flights were delayed, although we were luckier than many. When we...more

Big E-Cig Developments

by Klein Moynihan Turco LLP on

News out of New York and New Jersey this week indicates that additional e-cig regulations could soon affect consumers, manufacturers, and marketers alike. Given the size of the market, it is incumbent to keep a watchful eye...more

FTC Submits Comment To Aid NTIA In Developing Internet of Things Guidance

by Ballard Spahr LLP on

In its latest effort to address security concerns about Internet of Things (IoT) devices, the Federal Trade Commission (FTC) has submitted public comments to the National Telecommunications and Information Administration's...more

Outsourcing in the Pharmaceutical and Life Sciences Sectors – A UK Perspective

Pharmaceutical and Life Sciences companies operate in a demanding environment and face diverse challenges such as pricing pressure, increased regulatory requirements and mounting costs. With this backdrop, they have, starting...more

New U.S. Supreme Court Opinion Concerning Specific Jurisdiction in U.S. Courts

The United States Supreme Court issued its long-awaited opinion in Bristol-Myers Squibb Co. v. Superior Court of San Francisco County, 582 U.S. ____ (2017). Fortunately, the Supreme Court resisted the opportunity to revisit...more

Targeting Generic Drug Prices

by Blank Rome LLP on

For years, states and the federal government focused their drug pricing enforcement efforts on higher priced and more expensive branded drugs. Not surprisingly, private qui tam lawyers followed on the coattails of these...more

Fourth Circuit Punts West Virginia Innovator Liability Issue

by Reed Smith on

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when...more

Tobacco companies sue state for cigarette fee

by GableGotwals on

The tobacco fee’s critics warned that the state might get sued because of the measure, and they were right. Tobacco companies filed a lawsuit Wednesday to argue the measure is unconstitutional. Tobacco giant Phillip Morris...more

En Banc Opinion Could Set Precedent for Tied-House Laws

by McDermott Will & Emery on

On June 14, 2017, the en banc (full) Ninth Circuit Court of Appeals issued the attached opinion in the case of Retail Digital Network v. Prieto, No. 13-56069....more

Tax incentives in Puerto Rico: a quick introduction

by DLA Piper on

To promote, attract and develop key industries, sectors and activities, Puerto Rico offers a spectrum of economic incentives, among them low fixed income tax rates, partial and/or total tax exemptions, income tax credits and...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

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

by Hogan Lovells on

Supply chain development is at the heart of any ability for Africa to "Stand Up". Without urgent improvement Africa risks remaining a supplier of primary materials to which others add value, leaving it vulnerable to the...more

Trade Agreements Leading Up to NAFTA Renegotiations, US Industry Response

by Cozen O'Connor on

While formal NAFTA renegotiation has not begun, there has been movement by the administration to begin reshaping trade deals with both Mexico and Canada since President Trump announced his plans and sent notice to Congress to...more

Trade Secrets May Retain Protections Despite Disclosure to Single Competitor

by Seyfarth Shaw LLP on

The Ninth Circuit recently held in United States v. Liew that it was not plain error for the district court not to instruct the jury that disclosure “‘to even a single recipient who is not legally bound to maintain [a trade...more

Filling in the Gaps on Medical Device Cybersecurity

by Hogan Lovells on

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Preparing for the Inventory Reset: It Is Not That Easy

With the recent release of the 2016 Chemical Data Reporting (CDR) dataset and the initial interim list of active substances released with the February 2017 copy of the Toxic Substances Control Act (TSCA) Inventory...more

Are We Due for a Makeover?

by Hogan Lovells on

Many have questioned what affect a proposed legislative facelift, to the cosmetic industry, will have on manufacturers, retailers and, of course, on consumers. According to the Department of Trade and Industry, the total...more

EPA Proposes Extended Deadlines for Formaldehyde Emission Standards in Composite Wood Products

The Environmental Protection Agency has issued a direct final rule that would extend compliance deadlines in its Formaldehyde Emission Standards for Composite Wood Products. While this direct final rule does not address the...more

Use of the Chemical Name in Managing New Chemical Polymers under the Amended Toxic Substances Control Act

One of the consequences of the new Toxic Substances Control Act (TSCA) is the need for the U.S. Environmental Protection Agency (EPA) to review and make determinations under Section 5(a)(3)(B) on premanufacture notification...more

Medical devices – South Africa's changing landscape

by Hogan Lovells on

Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa.  Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices...more

Interesting Update: “Manufacturing” Law: Courts Join the States to Fill the Void

In a May 16 Blog Post, I reviewed several cases dealing with the question of whether Title VII’s ban on discrimination “because of . . . sex” included a ban on discrimination “because of sexual preferences.” I summarized...more

Higher Regional Court Düsseldorf: manufacturer cannot ban retailer from use of price comparison engines

by Bryan Cave on

In order to protect brand image, the quality of pre-sale service, and the pricing structure of their products, manufacturers undertake a variety of measures to sell products to their retailers. Thus, clauses which prohibit...more

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