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Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

Act II: Oral Argument in Amgen v. Sandoz is heard at the Court of Appeals for the Federal Circuit

The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more

Must the "Maker" of a False Statement have "Ultimate Authority" over that Statement to be Subject to Liability for Securities...

This case involved a civil enforcement action by the Securities and Exchange Commission (SEC) against certain public relations companies and their principals, alleging violations of—among other things—Section 17(a) of the...more

Mobile Privacy Rules to Be Enforced Starting September 1, 2015

All businesses acting in the mobile ecosystem—including app developers, analytics companies, advertising networks, app platform providers, and providers of devices and related services—should be aware that the Digital...more

FinCEN Resolves First Enforcement Action Against Virtual Currency Exchange

On May 5, a virtual currency company and its subsidiary agreed to pay a $700,000 civil money penalty for violating multiple provisions of the Bank Secrecy Act (BSA), in which both companies acted as a money service business...more

FinCEN and Department of Justice Settle Anti-Money Laundering Charges Against Crypto-Currency Company Ripple Labs

On May 5, Ripple Labs (Ripple) entered into a consent decree with the Financial Crimes Enforcement Network (FinCEN), under which Ripple admitted to conduct that violated U.S. anti-money laundering (AML) laws and agreed to...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

Where Are We Now? The NIST Cybersecurity Framework One Year Later

The National Institute of Standards and Technology (NIST) released its Cybersecurity Framework (Framework) almost 15 months ago and charged critical infrastructure companies within the United States to improve their...more

Over 4,400 comments on FAA’s proposed drone framework; Amazon wants less restrictions and more room for technological advancement

The comments period closed on April 24, 2015, for the Federal Aviation Administration’s proposed drone framework and regulations, and there were over 4,400 comments submitted. Among those opposed to the limited scope of the...more

SEC Issues New Cybersecurity Guidance for Investment Funds

On April 28, the Securities and Exchange Commission (SEC) Division of Investment Management (the “Division”) published a Guidance Update setting forth cybersecurity concerns and advice for the registered investment ...more

Washington Amends its State Data Breach Notification Law

On April 13, the Washington State Senate unanimously passed an amendment to the state’s data breach notification law. The amendment, which was requested by Washington Attorney General Bob Ferguson, and which we discussed in...more

SEC Secures Victory on Fraud Allegations Against Technology Executive

The US District Court for the District of Columbia took the unusual step of granting summary judgment against a technology company executive who the Securities and Exchange Commission accused of various violations of the...more

Assuring Regulatory Compliance Doesn’t Get Lost in Translation

With the expansion of large multinational corporations into developing countries such as Russia, Brazil, India, Mexico and China, a proliferation of global regulatory enforcement actions, including anti-bribery and...more

Prosecutors Strike Gold in Retailers’ Dumpsters with Hazardous Waste Enforcement Action

Retailers should implement hazardous waste management plans, even for simple consumer goods, as California, New York and other states launch aggressive enforcement campaigns. In recent years, California prosecutors...more

Orthofix secures option to acquire eNeura for $65 million

On March 31, 2015, Orthofix International N.V. announced it entered into an 18-month option agreement to acquire eNeura, Inc. Orthofix’s website states that the focus of the company is on “improving patients’ lives by...more

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more

The SEC and the Pharmaceutical Industry - Recent Commentary by the SEC's Enforcement Director Identifies Areas of SEC Focus...

Recently, the United States Securities and Exchange Commission’s (“SEC”) Enforcement Director, Andrew Ceresney (“Ceresney”), spoke to pharmaceutical compliance personnel at the CBI’s Annual Pharmaceutical Compliance Congress...more

NAIC Amps Up Cybersecurity Oversight

The NAIC has begun its efforts to amp up state insurance department oversight of cybersecurity practices with the release of two documents for public comment. The first, entitled Principles for Effective Cybersecurity...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Another Good Reason to Pay Heed to Cyber Security

For many companies, the prospect of a dreadful, costly and reputation-damaging cyber-attack and data breach is all the motivation they need to assess and improve their cyber security and data protection posture RIGHT NOW. ...more

Privacy commissioner to audit 21 privacy policies for compliance: it may be you!

The Australian Privacy Commissioner (Commissioner) is preparing to conduct an assessment of 21 online privacy policies at random. The Commissioner also noted: "[we've] been talking for a long time about the need to build...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

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