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Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

Life Sciences Spotlight - Asia Pacific Issue 7, 2016

Welcome to the seventh edition of Life Sciences Spotlight, and our very first AusBiotech/Biofest conference edition. We are very pleased to provide updates on a number of developments in the life sciences sector across...more

Federal Court Rejects Foreign Employee’s Attempt to Avoid Forum Selection Clause on Grounds He Signed Under Duress Upon Arriving...

Earlier this fall, the U.S. District Court in Massachusetts transferred an employee’s declaratory judgment action to the Eastern District of Michigan pursuant to a forum-selection clause in a non-compete agreement over the...more

3 Guidelines to Maximize Value of Data

Imagine you are the CEO of company sitting across from an interviewer. The interviewer asks you the age old question, “So tell me about your company’s strengths and weaknesses?” You start thinking about your competitive...more

Edward Snowden, Chelsey Manning and the Human Dimension of Information Security. Kate Bischoff Explains

Kate Bischoff worked for the State Department in the Middle East during the Edward Snowden and Chelsey Manning scandals. Kate also conducted training for the State Department for employees on information security. Kate...more

Fujifilm Kyowa Kirin Biologics Announces Successful Adalimumab Biosimilar Trial Results

On October 19, Fujifilm Kyowa Kirin Biologics (a joint venture between Fujifilm and Kyowa Hakko Kirin), announced successful results in the global Phase 3 study of its Humira® (adalimumab) biosimilar candidate, FKB327. ...more

DC Circuit Finds OSHA “Interpretation” Narrowing Retail Exemption Under the Process Safety Management Standard Really a...

Seyfarth Synopsis: In a challenge brought by trade associations for the farm supply and fertilizer industries, the D.C. Circuit vacates OSHA memorandum narrowing the retail exemption from the PSM standard. The U.S....more

Privacy Tip #57 – Do Those Chip Credit Cards Really Protect Me from Fraud?

There are a half a billion chip cards in the market right now. They have been touted to improve security and reduce credit card fraud. But do they? According to a new report, both Visa and MasterCard have reported that...more

Energy Sector Alert Series: Brexit and Energy - Leaving the EU While Staying Connected

In this eight-week alert series, we are providing a broad look at current and emerging issues facing the energy sector. Lawyers from across the firm are discussing issues ranging from cybersecurity, antitrust and intellectual...more

Health Update - October 2016

Defining and Resolving the Provider Data Dilemma - Editor’s Note: Provider data drives the most fundamental processes in the healthcare system. Inaccurate provider data puts patient care and billions of dollars at risk....more

NASA Announces Beyond Visual-Line-of-Sight UAS Test Flights

National Aeronautics and Space Administration (NASA) plans to fly unmanned aircraft systems (UAS; commonly known as drones) this month beyond visual line-of-sight of their operators to test planning, tracking and alerting...more

It’s Hunting Season. For Unicorns? Lawsuit Against Theranos Signals Trend In Investors Going After Late-Stage Start-ups

Last week brought more bad news for private blood testing company Theranos Inc., as San Francisco-based Partner Fund Management L.P. (“PFM”) launched a suit claiming that it was duped into making a $96.1 million investment in...more

Federal Banking Agencies Propose New Requirements for Managing Cyber Risk

Three federal banking agencies have announced plans to develop new rules that would establish cyber risk management and resiliency standards for large interconnected entities under the agencies' supervision, as well as those...more

SEC Fines Fantasy Stock Market App Developer

The Securities Exchange Commission (“SEC”) recently fined New York-based Forcerank LLC (“Forcerank”) $50,000 in connection with charges that Forcerank’s fantasy stock market mobile app illegally offers complex derivative...more

California Attorney General 'Crowdsources' Reporting of Privacy Policy Violations

This initiative by the Attorney General is effective immediately and is just the latest example of California’s effort to increase enforcement of laws aimed at protecting the privacy and data security of individual consumers....more

Should Hotels, Restaurants, Bars, and Shopping Centers Stop Offering Open WiFi Connections?

The answer in Germany is “yes.” To understand why, you have to understand the principle of “co-liability” or Störerhaftung. Under the principle of co-liability, operators of an open WiFi network can be held liable for the...more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

EU-US Privacy Shield: What You Need to Know for Transatlantic Data Transfers

The flow of data across international borders is crucial to commerce in today’s global economy. After last year’s invalidation of the Safe Harbor framework, which enabled companies to transfer personal data from the EU to...more

Obama’s Not Slowing Down On Cuba: New Steps Forward Open Doors (and Humidors!) for Collaboration

With fewer than 100 days left in office, President Obama is not slowing down on his efforts to normalize relations between the United States and Cuba. Today, several changes to the Cuban Assets Control Regulations (CACR) and...more

Manatt Digital - October 2016

A Message From Our Chair: Once again we are very pleased to provide you with another issue of the Manatt Digital newsletter. In this edition we revisit the topic of mergers and acquisitions, an important area of focus...more

Your Daily Dose of Financial News

For a start-up looking to unseat Bloomberg as the go-to insider source for financial news [other than this blog, of course], there’s a surefire way to gain some instant credibility: hire one of Bloomberg’s former top execs,...more

UK ICO Offers Guidance on Privacy Notices Under the GDPR and the UK Data Protection Act

In an anticipated guidance, the United Kingdom's Information Commissioner's Office (ICO) updated its code of practice for privacy notices titled Privacy notices, transparency and control (the Code). Significantly, the ICO has...more

FCPA Compliance Report-Episode 286-Use of Technology in Supply Chain Risk Management [Video]

Software platforms can provide a lot of efficiencies such as a reduction of time, resources and a more manageable audit trail. Still, software cannot do everything. Subject matter expertise is still essential to building a...more

Newly launched online complaint form in California boosts incentive to post accurate privacy policies

Online businesses and those with mobile applications have a new incentive to post privacy policies that comply with the California Online Privacy Protection Act (CalOPPA). California Attorney General Kamala Harris launched...more

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