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Tobacco Cases Expose Tension Between Antitrust and Public Health

A recent decision of the European Court of Justice (“ECJ”) regarding the sale of tobacco products highlights a long-standing tension between two sets of laws: antitrust/competition laws, which seek to keep products affordable...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Top Takeaways from IAPP

The world of privacy grows every day as more data goes through the cloud. The new trends and weekly data breaches make conferences like the Global Privacy Summit all the more relevant. Earlier this month we went to...more

FCPA compliance and Ethics Report-Episode 249-Reflections on Cuba, with Adam Turteltaub [Video]

In this episode, I share some reflections and observations on Cuba with Adam Turteltaub who was coincidently on a tour in Cuba at the same time as myself. ...more

Public Health Organizations Urge Congress to Reject Trans-Pacific Partnership Agreement

In a letter sent to members of Congress earlier this month, 58 public health organizations urged Congress to reject the Trans-Pacific Partnership (TPP) in its current form, stating that the coalition was "alarmed by the...more

U.S. Market Entry for the German Healthcare IT Company

The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more

DHS Warns of New Ransomware Threats

The Department of Homeland Security (“DHS”) recently issued a joint alert with the Canadian Cyber Incident Response Centre warning of two new ransomware threats behind recent well-publicized attacks against healthcare...more

China Issues First Update to Medical Device Clinical Trial Guidelines in 12 Years

The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years. The finalized revision to the 2004 Medical Device Clinical Studies Rules...more

Your daily dose of financial news The Brief – 4.11.16

The UK’s Daily Mail is reportedly joining Verizon in the field of suitors for Yahoo’s assets – WSJ - It’s no surprise when mega mergers attract the government’s attention, as we’ve seen in past weeks around here. But...more

Indiana Medical Device Manufacturer’s Deferred Prosecution Agreement with DOJ Extended for a Second Time

On March 25, an Indiana-based medical device manufacturer announced that the deferred prosecution agreement it entered into with the DOJ to settle FCPA charges in 2012 would be extended a second time. The company reported...more

Pharmaceutical Company Settles with SEC Regarding FCPA Offenses in China

On March 23, the SEC announced that it settled FCPA allegations with a Switzerland-based pharmaceutical company, via a cease and desist order finding that the company violated the FCPA’s book and records and internal controls...more

Novartis Agrees to Settle Bribery Charges Against Chinese Subsidiaries for $25 Million

On March 23, 2015, Swiss-based pharmaceutical company Novartis AG (“Novartis”) reached a civil settlement with the United States Securities and Exchange Commission (“SEC”) for violating the internal controls and books and...more

Africa Update - March 2016 #4

Leading the News - Libya - On March 28th, Libya’s United Nations (U.N.)-backed unity government accused authorities in Tripoli of closing down the capital’s airspace to prevent it from travelling to Libya from...more

Africa Update - March 2016 #3

Leading the News - Republic of Congo - On March 20th, the Republic of Congo (ROC) held voting in a presidential election that was predicted to see President Denis Sassou Nguesso extend his three-decade rule....more

Novartis FCPA Enforcement Action, Part II

Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

Novartis FCPA Enforcement Action, Part I

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

Foreign Corrupt Practices Act Alert

Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...more

European Life Sciences Review: Issue 2

Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

AGG Food and Drug Newsletter - March 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Africa Update - March 2016 #2

Leading the News - Cote d’Ivoire - On March 13th, Al Qaeda in the Islamic Maghreb (AQIM) gunmen armed with assault rifles stormed the beach hotels in Grand-Bassam, a region population with Ivoirian and Western...more

New EU/US Privacy Shield Details Announced Program Includes Provisions for Pharmaceutical and Medical Products

On February 29th, the European Commission (the “Commission”) published the details of the new EU/US Privacy Shield program (“Privacy Shield”) which is intended to replace the EU/US Safe Harbor (“Safe Harbor”) program that was...more

Amendments to license conditions for importing medicines have come into effect (Ukrainian)

Starting with 1 March 2016, the changes to License Conditions for Conducting Commercial Activities in Import of Medicines (the License Conditions), which introduce a set of requirements to the companies importing drugs into...more

Amendments to license conditions for importing medicines have come into effect

Starting with 1 March 2016, the changes to License Conditions for Conducting Commercial Activities in Import of Medicines (the License Conditions), which introduce a set of requirements to the companies importing drugs into...more

Africa Update - March 2016

Leading the News - Somalia - On March 5th, the U.S. military, in self-defense and in defense of African Union (AU) Mission in Somalia (AMISOM) partners, conducted an airstrike against Raso Camp, a training facility...more

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