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Administrative Agency Science, Computers & Technology Consumer Protection

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

Presidential Council Releases Infrastructure Cybersecurity Report And Recommendations

by King & Spalding on

On August 22, 2017, the President’s National Infrastructure Advisory Council (“NIAC”) issued a Report on securing critical U.S. infrastructure against cyber-attacks. The Report states that the U.S. is underprepared for the...more

FDA and FTC Solicit Consumer Complaints About Dietary Supplement Marketing

by Pepper Hamilton LLP on

The Food and Drug Administration and the Federal Trade Commission have jointly requested that consumers report dietary supplements that “didn’t work as promised” or that are marketed with “unbelievable” claims. Consumers may...more

FTC Competition Director Highlights Enforcement Priorities in the Pharmaceutical Industry

Last week Markus Meier, the Acting Director of the Bureau of Competition at the Federal Trade Commission, gave testimony to the House Judiciary Committee concerning “Antitrust Concerns and the FDA Approval Process.” ...more

LabMD – FTC Face-Off Continues Over FTC’s Data Privacy Authority

by Patrick Law Group, LLC on

The U.S. Court of Appeals for the Eleventh Circuit recently heard oral arguments in LabMD, Inc. v. Federal Trade Commission, the long-running dispute over the FTC’s authority to impose liability for data security breaches...more

A question of harm: LabMD to face off with FTC at 11th Circuit

In a consequential test of the Federal Trade Commission’s authority as a data security regulator, the U.S. Court of Appeals for the Eleventh Circuit will hear argument tomorrow in a case that will determine whether the agency...more

Proposed BROWSER Act Would Require ISPs and Edge Service Providers to Give Users Opt-in and Opt-out Rights for the Use and...

by WilmerHale on

On May 18, 2017, Martha Blackburn (R-TN), Chairman of the House Committee on Energy and Commerce’s Subcommittee on Communications and Technology, introduced H.R. 2520, the Balancing the Rights of Web Surfers Equality and...more

US Comptroller of the Currency Discusses Fintech

by Shearman & Sterling LLP on

US Comptroller of the Currency Thomas Curry provided remarks describing actions the OCC has taken to meet the needs of all types of consumers, businesses and communities in the US. Specifically, he described a new department...more

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

by Jones Day on

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more

EPA Proposes Rules to Implement TSCA Reform

by Jones Day on

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016. We previously summarized that bill's key changes to the Toxic Substances Control Act ("TSCA"). This Commentary highlights...more

FDA Clarifies “Intended Use” for Drugs, Devices, and Tobacco Products

by McDermott Will & Emery on

In its Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule), FDA codifies its long-standing...more

What is the FTC Doing About Privacy and Drones?

by Orrick - Trust Anchor on

Last week, as part of its Fall Technology Series, the Federal Trade Commission (“FTC”) hosted a much-anticipated workshop to explore the privacy concerns associated with drones. Although many in the audience hoped that this...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

by Morgan Lewis on

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

by McDermott Will & Emery on

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

September 2016 Update on Significant DOT, FAA and Other Federal Agencies’ Aviation-Related Regulatory Actions

by Cozen O'Connor on

This edition of the Cozen O’Connor Aviation Regulatory Update discusses DOT’s selection of carriers to operate U.S.-Havana and U.S.-Tokyo (Haneda) air services, the FAA’s implementation of its small unmanned aircraft...more

FTC Expands Its Role In Cybersecurity Enforcement By Reviving LabMD Action

by King & Spalding on

On Friday, July 29, 2016, the Federal Trade Commission (“FTC” or the “Commission”) overturned the decision of one of its administrative law judges (“ALJ”) from November 2015 in a suit against LabMD, Inc., now finding LabMD...more

President Obama Signs GMO Labeling Bill

Four weeks after Vermont’s controversial legislation regulating the labeling of foods containing genetically modified organisms (GMOs) took effect, President Obama has signed into law bill S. 764, which puts in place the...more

No Harm? No Matter. FTC Broadens Data Security Liability

No harm, no foul? Not according to the FTC. On July 29, 2016, the Commission held that a showing of tangible injury was not necessary in order for company acts and practices to be considered unfair. The case, In the...more

FTC: LabMD Tests Positive for “Unfair” Security Practices

LabMD’s lack of data security measures resulted in the FTC Commission overturning an Administrative Law Judge (“ALJ”) decision that previously dismissed charges against the company in November. LabMD performed laboratory...more

FTC Plants A Flag With LabMD Ruling: What This Means for Enforcement

On Friday, the heads of the Federal Trade Commission overruled the decision of the Administrative Law Judge (“ALJ”) in In the Matter of LabMd., Inc. The FTC concluded that the ALJ had erred in dismissing the Commission’s case...more

Breaking News: FTC Vacates ALJ’s Ruling and Finds LabMD Liable for Unfair Data Security Practices

In a ruling issued this morning, the Federal Trade Commission found that LabMD, the defunct Atlanta-based cancer detection lab, failed to protect patient information and is liable for unfair data security practices. The...more

Toxic Substances Control Act Overhauled Chemical Risk Regulation in the U.S. Joins the 21st Century

by King & Spalding on

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act). Passed with significant bipartisan support, the Act is the first major update to a federal...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...more

Stop Faxing

by Brooks Pierce on

I’ve long thought that sending faxes was a pretty silly means of communication. Don’t send me a fax. I don’t want it. At some point I’m hoping that even my kids’ doctor’s office will get dragged into the 20th century and...more

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