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Antitrust & Trade Regulation Science, Computers & Technology

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FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Ad Groups Ask FTC To Focus On Concrete Injuries, Not Subjective Emotional Distress

by King & Spalding on

Several advertising groups recently filed comments with the Federal Trade Commission (“FTC”) urging the organization to pursue enforcement actions only against security and privacy practices that cause “concrete injuries” to...more

10 Marketing Law Takeaways From ANA/BAA 2017

We just got back from the Association of National Advertising (ANA) and Brand Activation Association (BAA) Marketing Law Conference in Chicago, held earlier this week. With hundreds in attendance, and dozens of speakers...more

FTC’s New COPPA Guidance on Recording Children’s Voices: Five Tips for App Developers and Toymakers to Comply

by Fenwick & West LLP on

The Federal Trade Commission on October 23, 2017, provided guidance on how it will enforce the Children’s Online Privacy Protection Act (COPPA) with respect to audio recordings of children. This comes as part of a wave of...more

FDA Announces New Draft REMS Guidance

by Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

by Arnall Golden Gregory LLP on

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

Voice-Activated Devices May Collect Audio from Children

by Morgan Lewis on

A new FTC policy eliminates the requirement to obtain parental consent to collect a recording of a child’s voice in certain circumstances....more

FTC Speaks Out on Children’s Voice Recordings

In a new Enforcement Policy Statement, the Federal Trade Commission (FTC) decreased the burden for operators with regard to the collection of certain audio voice recordings of children under the age of 13....more

FDA Issues Final Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more

FDA Issues Draft Guidance on Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

Celebrity ICO Endorsements: SEC, FTC, and CFTC Oversight

by Reed Smith on

Floyd Mayweather, a world famous boxing champion, recently used his Twitter and Instagram accounts to help a company raise more than $30 million in an initial coin offering (“ICO”). Other celebrities have similarly...more

Behavioral Advertising: What Companies Need to Know About Evolving Advertising Technologies

by McGuireWoods LLP on

Rapidly changing and complex technology, the rise of “Big Data” and an increasing focus on digital advertising has made advertising legal compliance an increasingly complex area for companies. In-house attorneys and their...more

Terms and Conditions Land Online Trader in Difficulty in Australia

by Jones Day on

The Ruling: A computer retailer was order to pay a fine for violating the Australian Consumer Law. The Impact: Businesses must ensure that the terms and conditions in their warranty notices comply with the law, or risk an...more

National security reviews 2017: A global perspective — Germany (Updated)

by White & Case LLP on

Stricter regime for reviews of inbound transactions applied by the Federal Ministry for Economic Affairs and Energy - Following a surge in political initiatives for stronger investment control at the German and European...more

Dutch Court Affirms Ban on Nonauthorized Online Resellers

by Jones Day on

The Ruling: On October 4, 2017, the Amsterdam District Court upheld Nike's ban on authorized distributors selling Nike products on the online platforms of unauthorized resellers. The Result: Under this Dutch ruling, a...more

Reverse-Payment Plaintiffs Mine Patent Litigation Record to Survive Summary Judgment

by Holland & Knight LLP on

We pointed out in a recent article that, based on recent decisions by the Courts of Appeals for the First and Third Circuits, private antitrust plaintiffs seeking damages from so-called “reverse-payment” settlement agreements...more

Mylan Resubmits EMA Applications for Trastuzumab and Pegfilgrastim

by Goodwin on

As we previously reported, earlier this year Biocon requested withdrawal and re-submission of its Marketing Authorization Applications for its trastuzumab and pegfilgrastim biosimilars with the European Medicines Agency...more

From the Mouths of Babes: FTC Issues COPPA Enforcement Policy Regarding Voice Recordings

by BakerHostetler on

On October 23, the Federal Trade Commission (FTC) released new guidance on how the Children’s Online Privacy Protection Act (COPPA) Rule may apply to audio recordings of children’s voices collected by websites and online...more

What blockchain can learn from the net neutrality debate: antitrust and regulatory aspects of “paid prioritization” for a nascent...

by Hogan Lovells on

First come, first served. That’s not the principle behind the clearance of Bitcoin transactions. Equally for other blockchain technology networks, the relevant factor to get a transaction on the next available block is not...more

FTC: Stay Stuck on Security

The Federal Trade Commission recently wrapped up its Stick with Security blog series, which dove deeply into data security lessons based on agency cases, closed investigations, and questions and comments from businesses....more

Protecting Kids' Information Under the COPPA Cabana

In August 2017, Disney and three of its software developer vendors were sued in a class action in California in which it was alleged that Disney collected children’s information in violation of the Children's Online Privacy...more

FTC Provides Guidance on Reasonable Data Security Practices (Part III of III)

by Patrick Law Group, LLC on

This is the third in a series of three articles on the FTC’s Stick with Security blog. Over the past 15 years, the Federal Trade Commission (FTC) has brought more than 60 cases against companies for unfair or deceptive...more

Privacy & Cybersecurity Update - October 2017

In this month's edition of our Privacy & Cybersecurity Update, we examine the European Commission's annual review of the Privacy Shield, a potential threat to the European Union's "standard contractual clauses," a push by...more

ITC Defers to FDA, Declining to Institute Section 337 Investigation

by Ropes & Gray LLP on

In what represents a departure from typical U.S. International Trade Commission (ITC) practice, the ITC on October 27, 2017 declined to institute a Section 337 investigation based on a complaint brought by Amarin Pharma, Inc....more

Brands Beware: FTC Continues Campaign on Social Media Influencer Disclosures

With much fanfare, the Federal Trade Commission (FTC) continues to take actions relating to so-called “social media influencers” who allegedly fail to disclose material connections to the products or brands they endorse....more

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