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FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

EU Environment Report

In this issue: *Chemicals: ..Commission amends Annex XVII to REACH Regulation as regards 1,4-dichlorobenzene ("DCB") in relation to air fresheners and deodorisers ..Commission adopts Delegated...more

Europe: National data protection authorities should be independent

Following a series of previous judgments, the Court of Justice of the European Union (CJEU) confirmed in the case of the Commission v Hungary (case C-288/12) the independence of national data protection authorities in the...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

FDA Releases Unique Device Identification Final Rule, Draft Guidance

On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI)....more

EU Data Protection Reform – Interview with Susan Foster, Member, Mintz Levin [Video]

Attorney and Solicitor Susan Foster, Member of Mintz Levin's Corporate & Securities Practice, discusses the proposed changes to the EU’s data protection and privacy rules. ...more

United States of America v. Ross William Ulbricht

Federal indictment against Silk Road founder Ross Ulbricht for narcotics trafficking, computer hacking, and money laundering

Full text copy of the federal indictment filed September 27, 2013 against Silk Road founder Ross Ulbricht – aka Dread Pirate Roberts, DPR, and Silk Road – for narcotics trafficking, computer hacking, and money laundering (the...more

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

Legislative Update Report - Apr 12, 2013

Federal Government Regulations: Canada Gazette, Part II, March 27, 2013: Contraventions Act - SOR/2013-41 Regulations Amending the Application of Provincial Laws Regulations. Farm Products...more

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more

Levick Weekly - March 1, 2013: The Libor Scandal; Prosecutors Have A New Plan

In This Issue: - The Food Safety Modernization Act - The LIBOR Scandal - Prosecutors Have a New Plan - Food Safety Compliance - A Hogan Lovells Roundtable - Lessons from the Oldest CEO Succession Plan on...more

Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

The Obama Administration issued a Report earlier this month, entitled "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," that sets forth its efforts to prevent trade secret misappropriation. The Report...more

EU Proposed Directive on Network and Information Security

On 7 February, the European Commission (EC) published an EU Cyber Security Strategy encompassing a proposed Directive on Network and Information Security (NIS Directive). The aim of the Strategy and NIS Directive is to...more

The Patent Prosecution Highway Pothole for Pharmaceutical Patents

The USPTO promotes the Patent Prosecution Highway (PPH) as a way to “fast-track” a U.S. patent application when a corresponding foreign application has been allowed, or when a corresponding PCT application has received a...more

Privacy in Latin America

Originally published in Privacy & Security Law Report on January 7, 2013. The privacy landscape in Latin America is undergoing significant changes. With the enactment or implementation of laws in Colombia, Costa Rica,...more

This Week in Washington - January 11, 2013

In This Issue: - DOMESTIC POLICY MATTERS - Congress is in recess this week. The House returns on Monday, and the Senate returns January 21st. Debt Ceiling, Budget & the Economy. The President’s Fiscal...more

Chinese Government Decision May Help Brands Protect Themselves

Anyone trying to stop Chinese counterfeiters learns almost immediately that most of the information that would ordinarily identify China-based owners of a URL or website is false. That makes it costly or impossible to...more

Random Border Searches of Electronic Devices - Is an End in Sight?

Since 2008, if you or your employees are traveling into the United States with a laptop, tablet or other electronic device, that device may be searched by border crossing agents, without cause or justification for suspicion....more

Marks of Excellence – the Lakers 33 Game Winning Streak and FCPA Compliance Tools

Sorry Bill Simmons, but today we celebrate one of the great modern day records of any American sports franchise. On this day 41 years ago, the Milwaukee Bucks beat the Los Angeles Lakers to end the Lakers 33 game winning...more

CFIUS Annual Report Shows Increase in Notified Transactions in 2011

The Committee on Foreign Investment in the United States (CFIUS) recently released the unclassified version of its annual report to Congress for transactions notified to CFIUS during the calendar year 2011. Most notably, the...more

New Draft Regulations Soften Impact of CASL, but Concerns about Jobs and Compliance Costs Remain

Revised draft regulations under Canada’s anti-spam legislation (CASL) have been issued by Industry Canada. While the draft regulations provide some relief to businesses, Industry Canada has elected not to address concerns...more

News from Abroad: Availability of Documents at the EPO -- EPO Board of Appeal Decision T1839/11

Originally published in Forresters on January 6, 2012. Background: The patent - NovozymesFollowing grant of a patent to Novozymes in November 2009, the patent was asserted in Denmark, Germany, the Netherlands...more

Consolidated DoD Central Adjudicative Facility Creates Change

A new, consolidated DoD Central Adjudicative Facility (CAF) has been established to improve the efficiency of adjudicating personnel security clearances (PCLs) at a time when there is a substantial increase in the number of...more

Upcoming Patent Law Changes Will Put Pressure on Patents

Originally published in Pharmaceutical Outsourcing’s website on December 2012. Patent law is changing rapidly. The changes are putting even greater pressure on patents as a tool for protecting a pharmaceutical or...more

Top Stories of 2012: #8 to #11

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

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