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FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on...

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size...more

FDA Seeks Suggestions Regarding “Natural” Food Labeling, but Will It Act?

Surprising nearly everyone, FDA has reopened a long dormant discussion regarding the meaning of the term “natural” in the labeling of food. Today’s Federal Register contains a notice from FDA that the agency has officially...more

CIA Director’s email account hacked

An anonymous hacker has contacted the New York Post to explain how he was able to hack into the CIA Director’s AOL email account. According to several reports, a high school student and his two friends implemented social...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

FDA is “Keeping up with Kardashians’” Social Media Posts

On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

FDA Update: New guidance released on mobile medical devices, medical devices data systems

Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug...more

Amarin Wins Truthful Off-Label Speech Challenge

On August 7, Citing the First Amendment, a Southern District of New York court ruled that FDA cannot limit a manufacturer’s “truthful and non-misleading speech promoting off-label use” of a drug and evaluated specific...more

Website Accessibility: Department of Justice’s Filings in Lawsuits Give Warnings

For many years, the U.S. Department of Justice, an enforcer of the accessibility provisions (Title III) of the Americans with Disabilities Act, applicable to public accommodations, has dragged its feet on promulgating...more

Upper Tribunal Criticises FCA's Approach To Publicising Decision Notices

We consider here the decision of the Upper Tribunal (Tax and Chancery Chamber) in Bayliss & Co (Financial Services) Limited and Clive John Rosier v the Financial Conduct Authority [2015] UKUT 0265 (TCC) in which the tribunal...more

FCC Open Internet Advisory Procedures - Possibilities and Potential Pitfalls

As we head into this long holiday weekend, the FCC gives us something to think about. To seek guidance or not to seek guidance, that is the question. Today, the FCC released its Open Internet Advisory Opinion Procedures....more

Marketing to Millennials [Video]

Does your legal counsel understand your customer? Your business? Your industry? At Ifrah Law, we understand all three and we strive to provide you with the expertise that will help you grow your business!...more

Advertising and Marketing News from Ifrah Law’s, Volume 6

Internet Advertising and Marketing Summer Newsletter from Ifrah Law with updates you won't want to miss!...more

FCC Fines AT&T $100,000,000 for Violation of Transparency Rule

In a recent enforcement action, the FCC fined AT&T $100,000,000 for violations of the Open Internet Transparency Rule (“Transparency Rule”). The Notice of Apparent Liability (“NAL”) for Forfeiture and Order stated that AT&T...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

FCC Releases Enforcement Advisory – Tells Broadband Providers to Take “Reasonable, Good Faith” Steps to Protect Consumer Privacy...

Come June 12, unless stayed by a federal court, broadband Internet service providers will be subject to expanded requirements to protect consumer privacy and new limitations on the use of customer data under the FCC’s recent...more

FCC Adopts Emergency Information Accessibility Rules for Second-Screen Devices

At its May 21, 2015, Open Meeting, the Federal Communications Commission (FCC) adopted new rules requiring visually displayed emergency information to be available aurally on “second screens” – such as tablets, laptops, or...more

US House of Representatives Holds Hearing on the .SUCKS New gTLD and ICANN Accountability and Stakeholder Trust

On May 13, 2015, the US House of Representatives Judiciary Committee's Subcommittee on Courts, Intellectual Property, and the Internet held a hearing on "Stakeholder Perspectives on ICANN: The .SUCKS Domain and Essential...more

Mobile Privacy Rules to Be Enforced Starting September 1, 2015

All businesses acting in the mobile ecosystem—including app developers, analytics companies, advertising networks, app platform providers, and providers of devices and related services—should be aware that the Digital...more

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