Administrative Agency Consumer Protection Science, Computers & Technology

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Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more

OPM admits 5.6 million fingerprints stolen during breach

The Office of Personnel Management (OPM) reported yesterday that fingerprint data stolen during the breach of almost 22 million Americans’ data is estimated to be 5.6 million instead of the original estimate of 1.1 million....more

OPM data breach update–$133 million contract awarded to vendor

The Office of Personnel Management (OPM) and the Defense Department announced this week that a Portland, OR based vendor has been selected to assist with breach notification and credit assistance for the almost 22 million...more

OPM Breach Update

In response to the massive OPM data breach, the government has been searching for a vendor to provide identity protection services for the almost 22 million individuals affected. Bids were due last week, and the chosen vendor...more

UK’s First Ever Right To Be Forgotten Enforcement : Google In The Firing Line Again

The UK’s Information Commissioner’s Office (ICO) has made what appears to be its first “right to be forgotten” enforcement action against Google Inc. The ICO issued the notice on 18 August 2015, ordering Google to remove nine...more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...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

OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian...more

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

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