News & Analysis as of

Antitrust & Trade Regulation Updates

Read Antitrust & Trade Regulation updates, alerts, news, and legal analysis from leading lawyers and law firms:

China FDA Releases Guidance on Acceptance of Foreign Medical Device Study Data

by Ropes & Gray LLP on

On January 10, 2018, the China Food and Drug Administration (“CFDA”) announced the implementation of the Technical Guidelines Governing Acceptance of Medical Device Clinical Data from Foreign Studies (the “2017 Guidelines”)....more

EU Court clarifies the scope of gun jumping under EU Law

by Bryan Cave on

One of the key concerns of merging parties in any transaction is the steps they are allowed to take prior to the clearance of the merger. A recent case before the Court of Justice of the European Union (Case C-633/16 Ernst &...more

FTC Releases Annual Privacy and Data Security Update

by Ballard Spahr LLP on

The FTC has released its annual report summarizing its activity during 2017 relating to privacy and data security issues.  In its self-declared role as “the nation’s primary privacy and data security enforcer,” the FTC...more

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

by Mintz Levin on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

Australia's ACCC Alarmed at Increasing Issues Arising from Consumer Guarantees

by Jones Day on

The Situation: The Australian Competition and Consumer Commission ("ACCC") has identified a 39 percent increase in consumer guarantee reports in 2017 as compared with 2016, from 21,000 to 29,000. Looking Ahead: The ACCC...more

Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust case against Sanofi-Aventis U.S. LLC (“Sanofi”), the manufacturer of Lantus...more

Frequency Check: Is Your UAS FCC Compliant?

by Benesch on

The past decade has seen a rapid increase in the use of unmanned aircraft systems (“UAS”) (sometimes, though unusually inaccurately, called “drones”). The integration of UASs into the national airspace continues to be an area...more

Episode 22 -- Test and Evaluate Your Ethics and Compliance Program

by Michael Volkov on

As more companies implement ethics and compliance programs, chief compliance officers are increasingly focusing on the need to test and evaluate their compliance program. An effective testing program provides important...more

FTC Wins Default Judgment Against Prize Scam Defendants

The Federal Trade Commission (FTC) put an end to a phony prize scam with a default judgment entered by a California federal court judge in a case that was part of an international law enforcement initiative against mass-mail...more

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

Caveat Emptor: Are Lengthier EC Merger Reviews the New Norm?

As merger reviews become more thorough and document-intensive, companies planning to engage in global M&A deals in 2018 should factor potentially lengthier merger reviews by the European Commission (EC) into their deal...more

IoT Device Companies: COPPA Lessons Learned from VTech’s FTC Settlement

by Patrick Law Group, LLC on

In “IoT Device Companies: Add COPPA to Your "To Do" Lists,” I summarized the Federal Trade Commission (FTC)’s June, 2017 guidance that IoT companies selling devices used by children will be subject to the Children’s Online...more

Toy Company Settles DOJ Complaint Alleging Violations of Children’s Online Privacy Rule and FTC Act

by Weiner Brodsky Kider PC on

The Federal Trade Commission (FTC) recently announced a settlement with an electronic toy manufacturer for violating the Children’s Online Privacy Protection Rule (COPPA) and the FTC Act. The COPPA Rule prohibits unfair or...more

AD-ttorneys@law

by BakerHostetler on

Are you really trying to use Jedi mind tricks to sell merch? Fan Disservice? That’s the accusation leveled by Truth in Advertising Inc., which claims that Skywalker’s Hollywood avatar, Mark Hamill, took so long to...more

EU & Competition Law Update - January 2018

by Bryan Cave on

When is pricing discriminatory? We reported in January 2017 on how a Portuguese Court had asked the Court of Justice of the European Union (“CJEU”) to provide guidance on when “discriminatory pricing applied to equivalent...more

ACCC Increases Enforcement of Consumer Guarantees Against Airlines

by Jones Day on

The Situation: Following consumer complaints, the Australian Competition and Consumer Regulator ("ACCC") has released a report reminding airlines of obligations when dealing with the flying public. Looking Ahead: The ACCC...more

Settlement Offers Guidance on What “Reasonable” Security Means Under COPPA

The FTC’s COPPA Guidance does an admirable job explaining the basics of what a business needs to do to comply with COPPA, but is vague as to how a business must protect personal information collected from children. The COPPA...more

High Court Grants Certiorari in Vitamin C Antitrust Litigation

by Holland & Knight LLP on

On Friday, January 12, 2018, the United States Supreme Court agreed to hear the appeal of two Vitamin C purchasers in what has become known as In re: Vitamin C Antitrust Litigation. Appellants are seeking to overturn a 2016...more

FTC Staff Releases Paper Highlighting Key Privacy and Security Issues for Autonomous and Connected Vehicles

by WilmerHale on

The Federal Trade Commission Staff (FTC) released a new “Staff Perspective” on January 9, 2018, that highlights key privacy and data security issues related to autonomous and connected vehicles. The Staff Perspective outlines...more

Toying With Children’s Data: Lessons From the FTC’s First Connected Toys Settlement Action

by BakerHostetler on

Every year, especially around the holidays, more and more products that connect to the internet hit the market. For adults, connected home devices that act like personal domestic assistants have become increasingly popular....more

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

Reading Between the Blurred Lines

The Federal Trade Commission recently released a Staff Report regarding consumer recognition of native and search advertising entitled “Blurred Lines”, summarizing its findings from its self-styled “exploratory research”....more

EU Merger Control 2017: Competition in Innovation; EC Prohibiting Deals; Fines for Procedural Infringements; and EU Courts...

by WilmerHale on

2017 saw some highly significant investigations and court judgments in European Union merger control. Notably: ..After detailed investigations and subject to extensive divestments, the European Commission (“EC”) cleared...more

FTC Enforcement of COPPA for Internet of Things Reaches Flashpoint

by Morgan Lewis on

Galvanized by a confluence of charged factors—like privacy, cybersecurity, children, and the Internet of Things (IoT)—and sparked by recent assertions of Children’s Online Privacy Protection Act (COPPA) regulatory power, the...more

FTC Issues Staff Report on Consumer Recognition of Paid Advertising

by Davis Wright Tremaine LLP on

The Federal Trade Commission delivered the advertising industry an early holiday present in mid-December in the form of a staff report entitled “Blurred Lines: An Exploration of Consumers’ Advertising Recognition in the...more

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