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Privacy Update: Protecting Children From Cyber-Bullying

The Federal Government's Enhancing Online Safety For Children Bill 2014 Is A Significant Cyber Reform. The First Direct Response To Cyber-Bullying It May Also Herald A New And Targeted Approach To The Online Activity Of...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Prior Art Reference Does Not “Teach Away” if It Fails to Criticize, Disclaim or Discourage the Claimed Technique

Ultratec, Inc. v. CaptionCall, L.L.C. - Addressing the obviousness issue whether an asserted secondary reference impermissibly changes the principle of operation of a primary reference, the U.S. Patent and Trademark...more

Preemption and Primary Jurisdiction After Pom Wonderful

After the U.S. Supreme Court decision in Pom Wonderful LLC v. The Coca-Cola Co., __ U.S. __, 134 S.Ct. 2228 (2014), fear arose among national marketers that the decision would produce a wave of class actions challenging food,...more

Cost of Combination Doesn’t Obviate Obviousness

Polaris Wireless, Inc. v. TruePosition, Inc. - Addressing the issues of patent priority dates (where the asserted priority document did not share an inventor with the challenged patent) and motivation to combine, the...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

Marriott Fined $600,000 For Wi-Fi Jamming

On October 3, 2014, Marriott International entered into a consent decree with the Federal Communications Commission (FCC) where Marriott agreed to pay a $600,000 fine for jamming conference guests' Wi-Fi hotspots at the...more

Advertising Law - December 2014 #2

Uber’s Privacy Mess Results in Legislative Inquiry - Providing a lesson in how not to handle a privacy policy, car service app Uber is now facing questions from the Senate Subcommittee on Privacy, Technology and the...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

The New Promotional Rules: “There Are No New Promotional Rules”

There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential...more

PTAB: Claims for Method of Authenticating a Website are Patentable under Alice and Section 101

In a CBM petition filed by petitioners PNC Bank, U.S. Bank, and Bancorp, the petitioners sought review of U.S. Patent No. 7,631,191, which claims a method of authenticating a web page. The petition challenged the validity of...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Main giveaways from our “Second Screen” webinar

No doubt, Second Screen, Social TV and other enhanced broadcasting applications are increasingly popular. Here are some giveaways from our “Second Screen” webinar. - Trends. As stated by Accenture’s Francesco...more

New draft regulation on resolution of disputes between electronic communication operators

The Italian Communication Authority (AGCOM) published a new consultation on a draft regulation relating to the resolution of disputes between electronic communication operators....more

Record Actions Force Companies to Reevaluate How They Protect Consumers

Last week the FCC’s Enforcement Bureau announced that Verizon agreed to pay a record US$7.4 million to settle an investigation related to the company’s treatment of consumer personal information. Specifically, the Commission...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

FDA issues social media guidance

Earlier this month, the FDA released proposed two-part Guidance on Internet and social media intended to assist prescription drugs and medical device manufacturers to accurately communicate online about their products. The...more

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