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FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...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 Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

PHOs Banned in the U.S.: Landmark FDA Order Declares Partially Hydrogenated Oils No Longer Generally Regarded as Safe

On June 17, 2015, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Determination Regarding Partially Hydrogenated Oils (Order), finding there is “no longer a consensus that partially hydrogenated...more

OPM Hit by Massive Data Breach

On June 4, 2015, the U.S. Office of Personnel Management (OPM) announced that it was the victim of a data breach in which records of more than four million current and former agency employees were accessed. According to the...more

Finding a Cyber Safe Harbor in the SAFETY Act

Does your company provide or use a cybersecurity product or service? Are you concerned about the potential liability for yourself, your distributors and your customers if your cybersecurity product is used in an attempt to...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

FTC sued by blogger to release data security guidelines

The Federal Trade Commission (FTC) was sued this week by Philip Reitinger, a fellow blogger and former Deputy Undersecretary of the Department of Homeland Security. He is now President of VisionSpear LLC, an information...more

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more

The DOJ’s Cyber Incident “Best Practices” Guidance

The Cybersecurity Unit of the U.S. Department of Justice released in April its “Best Practices for Victim Response and Reporting of Cyber Incidents,” which it says reflects “lessons learned by federal prosecutors while...more

Are Cosmetics Gaining Higher Congressional and FDA Scrutiny?

Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting. Senators Dianne Feinstein (D-CA) and Susan...more

Do You Have a Data Breach Response Plan? U.S. Department of Justice Thinks You Should

In the wake of significant retailer data breaches in 2013 and 2014, and additional significant breaches continuing in 2015, a trend is clearly developing — an expectation of proactive risk identification and mitigation from a...more

The DOJ Sets Out to Establish Standard for Data Security Incident Response and Preparation

Organizations face threats to their data from all fronts, from sophisticated external attacks by hackers to employee error (as the 2015 BakerHostetler Incident Response Report showed). Recognizing the prevalence of these...more

California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more

King & Spalding Lawyers Attend DOJ Cybersecurity Industry Roundtable On Data Breaches

On Wednesday, April 29, King & Spalding Partner Phyllis Sumner and Counsel Nick Oldham participated in DOJ’s first Cybersecurity Industry Roundtable regarding data breaches. The Roundtable included several notable DOJ and law...more

DOJ Releases Best Practices for Victim Response and Reporting of Cyber Incidents

Last week, the Cybersecurity Unit of the Department of Justice (DOJ) issued a list of “best practices” for companies concerning preparing for and responding to cyber-attacks. The report details the lessons federal prosecutors...more

EPA Issues Interim Guidance Concerning Antimicrobial Data Requirements

On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces....more

ONC-HIT Releases Updated Guide for Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (ONC-HIT) released version 2.0 of its Guide to Privacy and Security of Electronic Health Information (the Guide). While the Guide clearly states that it...more

FDA Flexes Muscles Over Dietary Supplements

In a move designed to halt sales of popular workout stimulants, the U.S. Food and Drug Administration (FDA) recently issued warning letters to some 14 dietary supplement companies....more

Consent to Disclose Information in Response to a Consumer Complaint – Guidance from Canada

Not infrequently, customers may resort to consumer affairs columnists and other third parties, such as consumer advocacy groups, in order to resolve issues that they are having. In these circumstances, is there implied...more

LabMD Litigation Updates

We have been following this case closely. On April 16, the administrative law judge in the FTC v. LabMD case denied LabMD’s request to exclude the FTC from introducing new evidence into the proceeding regarding how Tiversa...more

Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

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

FTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement

In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to...more

FTC Seeks to Secure First Disgorgement in Nearly a Decade

The FTC announced yesterday that Cardinal Health, Inc. (“Cardinal”) has agreed to pay $26.8 million to resolve its investigation into the company’s alleged anticompetitive behavior. If approved by a federal court, the...more

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