Administrative Agency Consumer Protection Science, Computers & Technology

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Marriott Fined $600,000 For Wi-Fi Jamming

On October 3, 2014, Marriott International entered into a consent decree with the Federal Communications Commission (FCC) where Marriott agreed to pay a $600,000 fine for jamming conference guests' Wi-Fi hotspots at the...more

Congress Passes the National Cybersecurity Protection Act: Codifies National Cybersecurity Center & Creates Federal Agency Data...

The National Cybersecurity Protection Act of 2014 (NCPA) was passed by the House on December 8th, by the Senate on December 10th, and signed by the President on December 18th. Senate Committee on Homeland Security and...more

FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

Advertising Law - December 2014 #2

Uber’s Privacy Mess Results in Legislative Inquiry - Providing a lesson in how not to handle a privacy policy, car service app Uber is now facing questions from the Senate Subcommittee on Privacy, Technology and the...more

Technology may reduce fraud but doesn’t fix regulatory confusion

President Barack Obama recently announced the administrtion’s BuySecure initiative. At a meeting at the Consumer Financial Protection Bureau Oct. 17, the president outlined the program, aimed at increasing the security of...more

Lawmakers Seek Details On Consumer Data Breaches From Financial Institutions

On November 18, 2014, several major financial institutions received requests from lawmakers for detailed information about recent data breaches and for briefings from their corporate data security officials. The lawmakers...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

Data Privacy And Cybersecurity For Investment Funds

In This Presentation: - WHY IS DATA PRIVACY AND SECURITY IMPORTANT? ..Why is it important to protect data? ..SEC Cybersecurity Risk Alert ..FINRA Scrutiny - BEFORE THE BREACH ...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Work Plan Signals Expanded Calif. Green Chemistry Program

As part of its Safer Consumer Products Regulation (SCPR) under California’s Green Chemistry Initiative, the Department of Toxic Substances Control (DTSC) on September 13, 2014 issued its Draft Priority Product Three-Year Work...more

ALJ Denies LabMD’s Motion for Sanctions Against the FTC

Although the litigation between LabMD and the Federal Trade Commission (FTC) continues in the Eleventh Circuit, an administrative law judge has resolved one battle between the two entities. Chief Administrative Law Judge D....more

EU Set to Strengthen Data Protection Laws

Businesses that operate in the European Union (EU) may soon face a new set of data protection regulations. High-level discussions about a proposal to consolidate all individual EU-member nations’ data protection regulations...more

Pharmacy Compounding Update: Regulators Search for the Right Formula

Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding...more

Record Actions Force Companies to Reevaluate How They Protect Consumers

Last week the FCC’s Enforcement Bureau announced that Verizon agreed to pay a record US$7.4 million to settle an investigation related to the company’s treatment of consumer personal information. Specifically, the Commission...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more

Keeping Our Kids Healthy: Pediatric Medicine Development

Children are a precious commodity and it is important that they are cared for appropriately. Children deserve the best care so they can grow and live happy and fulfilled lives. Pediatric products development is in high demand...more

FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human...more

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