News & Analysis as of

Supply Chain

You're Always a Day Away: DSCSA Product Identifier Requirements Delayed

by Arnall Golden Gregory LLP on

In recently issued draft guidance related to the implementation of product identifiers under the Drug Supply Chain Security Act ("DSCSA"), FDA has stated that it intends to exercise enforcement discretion for a period of one...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Taking Advantage of the Global Supply Chain for Patent Examination

by Ward and Smith, P.A. on

Innovation and Traditional Patent Process - When you develop an innovation, its potential patentability is typically unknown, thus making it difficult to determine whether it is worth the significant expense involved if...more

New guidance for lawyers advising businesses on human rights risks

by DLA Piper on

On 17 July 2017, the International Bar Association Legal Policy and Research Unit (LPRU) released a Handbook for Lawyers on Business and Human Rights to provide guidance for business lawyers and their corporate clients on how...more

The False Claims Act: Why It Is Relevant To All Manufacturers

The False Claims Act (FCA) is a major civil enforcement tool used by the federal government to redress fraud causing monetary loss to the government. In the 2016 fiscal year, the federal government recovered over $4.7...more

Conflict Minerals – The European Drive for Greater Supply-Chain Transparency Continues

by Allen & Overy LLP on

The EU has finally adopted new transparency rules regarding so-called conflicts minerals being imported into the EU. This follows a series of policy initiatives from the European Commission to drive for greater transparency...more

Australia’s Consideration of a New Modern Slavery Act: What You Need to Know

Corporate counsel must increasingly assess the implications of new transparency statutes that require companies to make public disclosures as to their efforts to address certain human rights-related risks in connection with...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

Supply Chain Disruption and Litigation Trends in North Africa's Oil and Gas Industry

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Laurent Gouiffès discusses oil and gas supply chain disruption and litigation trends in North Africa, including Algeria, Libya, Tunisia, Morocco, and Egypt....more

Takata Declares Bankruptcy: What are the Key Next Steps for Suppliers?

by Foley & Lardner LLP on

On June 25, 2017, Takata’s US arm, TK Holdings Inc. and certain affiliates excluding certain foreign debtors such as Takata Corporation (Japan) (the “Takata US Debtors”), filed chapter 11 cases seeking bankruptcy protection...more

FCPA COMPLIANCE REPORT-EPISODE 337, JAMES GELLERT ON ASSESSING 3RD PARTY FINANCIAL HEALTH FOR COMPLIANCE

by Thomas Fox on

In this episode, I visit with James Gellert, CEO of RapidRatings, a company which uses a financial dialogue to determine third party supplier health and viability. Gellert explains what supply chain resilience is and how...more

FSMA: What Every Food Industry Executive Should Do & Why

by Strasburger & Price, LLP on

With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that manufacture, pack, process,...more

How Life Sciences and Pharmaceutical Companies Can Harness Opportunity in Their Supply Chains

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells counsel Penny Powell talks about disruptive technologies, the increasing trend towards collaboration and joint venture agreements, the opportunities and regulatory burdens...more

Taiwan: Cross-border opportunities amid global change: What Taiwanese businesses need to know about Brexit - Europe's complicated...

by White & Case LLP on

Since the United Kingdom (UK) joined the European Union (EU) 44 years ago, the UK and the EU had been working to progressively integrate their legal, economic and financial systems. Then last year, UK voters opted to "Brexit"...more

Risky IT Programs - The Use of Algorithms and Risk of Collusion under Antitrust Laws

by DLA Piper on

On 14 June 2017, the OECD published a Note from the EU on Algorithms and Collusion (DAF/COMP/(2017)12 - here) (the EU Note). An updated background note on Algorithms and Collusion was published by the OECD Secretariat on 9...more

We’ll Always Have…

by Reed Smith on

Next week, the advertising industry gathers in Cannes, France for its annual awards celebration. In addition to the much coveted Lion statuette, countless leaders in the industry will be on hand for networking, speeches, and...more

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

by Dorsey & Whitney LLP on

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

Suniva/SolarWorld Section 201 Solar Panel Proceeding

On May 23, 2017, the U.S. International Trade Commission ("USITC") initiated a proceeding under section 201 of the Trade Act of 1974 to determine if imports of crystalline solar photovoltaic ("CSPV") cells and modules are...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

EU & Competition Law Update – June 2017

by Bryan Cave on

Hope for a Cleaner Brexit After ECJ Ruling - In a ruling which is likely to have positive implications for a possible Brexit deal, the European Court of Justice (ECJ) on 16 May 2017 opened up the ability of the EU...more

InterConnect - Spring 2017

by Benesch on

Many, if not most, agreements between sellers of goods and logistics service providers (LSPs) contain a list of metrics that are used to evaluate various aspects of supply chain or provider performance. In theory, these...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

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

The New Conflict Mineral Regulation Will Apply from January 2021

by K&L Gates LLP on

The new EU rules on conflict minerals impose strict due diligence requirements on EU importers of gold, tin, tungsten and tantalum. On 19 May 2017 Regulation 2017/821, which sets out supply chain due diligence obligations for...more

The Supreme Court Makes an "Impression": Patent Exhaustion Defined

by Bryan Cave on

Earlier this week, the U.S. Supreme Court’s ruling in Impression Prods., Inc. v. Lexmark Int’l, Inc., 581 U.S. ___ (2017) reversed the Federal Circuit’s interpretation of the patent exhaustion doctrine. The Supreme Court held...more

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