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Online Advertisers Take Notice – Recent Canadian Decisions

The Office of the Privacy Commissioner (OPC) has released two important decisions this year on online behavioural advertising (OBA or interest-based advertising) so far this year. On March 25, 2015, the OPC released its...more

The FDA Gets an EARful on Label Changes

We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014...more

OSHA Announces Request for Information on Communication Tower Safety

On April 15, the Occupational Safety and Health Administration (OSHA) published in the Federal Register a Request for Information (RFI) on Communication Tower Safety. The agency requests that the communication tower industry...more

FCC Enters Into $25 Million Settlement Following Cell Phone Carrier Data Breach

On April 8, the Federal Communications Commission (FCC) announced a $25 million settlement with an international telecommunications carrier concerning the unauthorized release of the personal information of nearly 280,000...more

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

FTC Settles with Technology Company for Allegedly Misleading Consumers about Refunds

On April 7, the FTC announced a proposed settlement of an administrative complaint alleging that a web hosting provider violated the Federal Trade Commission Act. According to the press release, the company offered web...more

This Changes Everything: The FCC Open Internet Report and Order on Remand, Declaratory Ruling, and Order

I. Not Your Father’s Broadband - The Federal Communications Commission (FCC) on March 12, 2015, released a new template for future regulation of a basket of mass market retail services it has named “broadband Internet...more

FCC Imposes Record Penalty for Data Breach

On Wednesday, April 8, the Federal Communications Commission (FCC) entered a consent decree and levied a $25 million civil penalty against AT&T to settle a data breach that exposed the information of nearly 280,000 customers....more

Google’s Pole Attachment Rights in California on Hold for Now

The California Public Utilities CPUC (CPUC) released a Proposed Decision on February 20, 2015 denying a petition by Google Fiber Inc. (Google) to modify the CPUC’s Video Service Provider Decision or DIVCA Order. Google’s...more

Alert: FCC Continues Aggressive Action on Data Breaches

As noted in previous alerts, the FCC has dramatically increased its enforcement of data security practices and breaches resulting from what the FCC considers to be inadequate security measures. ...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

Canada Issues First Penalties Under Anti-Spam Law

CRTC imposes over US$900,000 in fines against two companies, reminding U.S.- and foreign-based businesses about possible liability under Canada’s Anti-Spam Law - This month marks the issuance of the first two enforcement...more

FDA Issues Guidance on Mobile Medical Devices

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

FDA Holds Public Hearing On Proposed Label Change Rule

On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

The FCC and the Uncertain Future of Privacy Oversight for Internet Service Providers

The Federal Communications Commission’s (“FCC”) net neutrality proceeding culminated this month with the release of an Order reclassifying broadband Internet access service as a common carrier Telecommunications Service...more

Can the U.S. – EU Safe Harbor Weather the Storm?

On 24 March, the Court of Justice for the European Union (CJEU) heard argument on a case that could significantly impact, if not invalidate altogether, the Safe Harbor framework that facilitates the flow of personal data from...more

Restrictions Eased for Communications-Related Items Exported to Sudan

On February 18, 2015, in a coordinated action, the Commerce Department's Bureau of Industry and Security (BIS) and Treasury Department's Office of Foreign Assets Control (OFAC) announced and implemented changes to the...more

EUROPE: EU-US data flows at risk? European Court of Justice today heard Facebook case.

Yesterday, the Schrems v. Irish Data Protection Commission case was brought before the Court of Justice of the European Union (‘CJEU’) for an oral hearing, following referral by the Irish High Court. While the final ruling by...more

Supreme Court Corner - Q1 2015

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. Patent – Decided: January 20, 2015 - Holding: When reviewing a district court’s resolution of subsidiary factual matters made during its construction of a patent claim,...more

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

FCC Shifts Net Neutrality into High Gear

On March 12, 2015, the FCC published its long-anticipated Net Neutrality order. The Final Rules stem from the question asked by the FCC in its May Notice of Proposed Rulemaking: “What is the right public policy to ensure that...more

FCC Releases Open Internet Order

On March 12, 2015, the Federal Communications Commission (FCC or “Commission”) released the full text of its Open Internet Order (“Order”). The rules adopted in the Order will become effective 60 days after publication in the...more

State Regulation of Broadband

The Order attempts to minimize the possibility of state regulation of broadband Internet access service (BIAS), leaving only the most limited role for the states. The Order reaffirms that BIAS is an interstate service for...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

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