On April 26, the U.S. Supreme Court heard arguments over whether to speed up the time it takes to bring to the market biosimilars. The case involved a section of the 2010 Affordable Care Act that created an expedited path for...more
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
On February 28, 2017, United Medical Instruments, Inc. (UMI), a California corporation, settled its potential civil liability with the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) in the amount of...more
The United Kingdom (UK) government served notice on March 29, 2017, under Article 50 of the Treaty on European Union that it intends to withdraw from the European Union (EU). There is no guide to managing a departure under...more
Douglas Adams, the late British author, wrote that “Don’t Panic” was printed in large, friendly letters on the cover of The Hitchhiker’s Guide to the Galaxy for two reasons: (i) the Guide looked insanely complicated to...more
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
On January 13, 2017, President Obama signed the Executive Order “Recognizing Positive Actions by the Government of Sudan and Providing for the Revocation of Certain Sudan-Related Sanctions” that revoked many U.S. economic...more
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
1/25/2017
/ 21st Century Cures Initiative ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Generic Drugs ,
Health Insurance Portability and Accountability Act (HIPAA) ,
International Arbitration ,
Medical Devices ,
OCR ,
Pharmaceutical Industry ,
Price-Fixing ,
Securities and Exchange Commission (SEC)
The Securities and Exchange Commission (SEC) and Department of Justice (DOJ) wrapped up 2016 on December 22 with a near record-breaking Foreign Corrupt Practices Act (FCPA) settlement involving Teva Pharmaceuticals and its...more
The 21st Century Cures Act (Cures Act) makes a number of changes affecting the pharmaceutical and biologics industries, and AGG previously has written on some of these changes. This update will focus on how the Cures Act...more
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
12/16/2016
/ 21st Century Cures Initiative ,
Business Associates ,
Covered Entities ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
OCR ,
Orphan Drugs ,
Pharmaceutical Industry
2016 was an active year for U.S. export control developments impacting U.S. pharma/device companies. We expect 2017 also to be busy, especially with the upcoming change in Administrations. This article briefly will review for...more
Ten days ago I was in Belfast, speaking on a joint Invest Northern Ireland- Catalyst program about doing business in the US. Much virtual ink has been spilled on this blog about when an Irish or Northern Irish company should...more
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
On September 28, the Office of Foreign Assets Control (OFAC) at the U.S. Department of the Treasury issued its Biennial Report of Licensing Activities Pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000,...more
I was recently asked whether the US had any regulations similar to the EU’s Commercial Agent Regulations–pursuant to which, upon termination or expiration of certain agency contracts, the agent would be entitled to an...more
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
On September 14, 2016, the President announced his intention to terminate the national emergency with respect to Burma, the effect of which will be to end the current U.S. sanctions program against that country as overseen by...more
Two recent settlements by the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) confirm that every U.S. life sciences company engaging in exports should have an effective U.S. export control compliance...more
Over the past two weeks, I’ve reviewed two non-disclosure agreements (NDAs) for Northern Irish companies that are expanding to the US. I’ve written about NDAs in the past: NDAs and You: Perfect Together. The NDAs were...more
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
Every life sciences company with international operations should have a robust Foreign Corrupt Practices Act (FCPA) compliance program as part of its overall compliance strategy. On April 5, 2016, the Justice Department...more
I’ve written several times (Minimizing ‘Alter Ego’ Risk for Irish and Northern Irish Parents of US Affiliates; and Effectively Using a Lightning Rod) about the need for Irish and Northern Irish companies to form a formal US...more
Previously, I’ve written how forming a U.S. affiliate can be like using a lightning rod for U.S. litigation risk. Properly used, a U.S. affiliate can help keep U.S. litigation risk away from the Irish/NI parent and its...more
When Irish and Northern Irish companies ask if there is *one* thing they can or should do to minimize the risk of operating in the US, I channel my inner Mr. McGuire (from the movie The Graduate) and say ‘process.’ It’s not...more