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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10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications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The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens.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

The Regulator Knows Best: British Columbia Court of Appeal Upholds Bylaws Prohibiting Customer Incentive Programs

by Field Law on

In Sobeys West Inc. v. College of Pharmacists of British Columbia, 2016 BCCA 41, the British Columbia Court of Appeal determined that it was reasonable for the College of Pharmacists to prohibit pharmacists from using...more

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two...more

ALJ Upholds $239,800 In Civil Monetary Penalties For HIPAA Violations

by King & Spalding on

Home health care provider Lincare, Inc. must pay $239,800 in civil monetary penalties for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, according to a February 3, 2016...more

Why is the Government Interested in my Drone?

by Murtha Cullina on

Everyone has heard of drones. Amazon is going to use them to deliver packages soon, right? What is a drone and what do individuals and businesses need to know about drone usage? Drones are defined simply an unmanned,...more

Izzet Sinan on What Telecom Antitrust Regulation Means For EU Integration [Video]

by Mimesis Law on

Izzet Sinan, partner in the Morgan Lewis's office in Brussels, talks about the interplay between antitrust regulations for the telecommunications industry and integration within the European Union....more

Reading the Section 5(a) Tea Leaves: What the end of 2015 may suggest about the FTC priorities in 2016

by Moore & Van Allen PLLC on

The end of 2015 represented a mixed bag for the Federal Trade Commission on privacy enforcement. In November, the FTC’s Chief Administrative Law Judge dismissed the FTC’s complaint against LabMD for a possible data breach of...more

While Not Quite a Rash of Enforcement, FDA Takes Action in 2015 Against Cosmetic Products Making Unapproved Drug Claims

by Arnall Golden Gregory LLP on

To paraphrase, admittedly horribly, the Cole Porter classic, “I’ve Got You Under My Skin,” a number of cosmetic companies got under the Food and Drug Administration’s (FDA) skin in 2015 for making unapproved new drug claims....more

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