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Life Sciences Exports

The Volkov Law Group

Life Sciences Company Escapes Criminal Charges for Employee’s Illegal Export Scheme

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Sigma-Aldrich, Inc., d/b/a MilliporeSigma (“MilliporeSigma”), a U.S. life sciences company based in Massachusetts, escaped criminal charges for export control violations, despite a former sales person’s scheme to illegally...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. In This Month’s E-News: December 2022

The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more

Vicente LLP

What is the Process for Federal Psilocybin Registration?

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We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more

American Conference Institute (ACI)

[Complimentary Webinar] Mitigating Sanctions and Export Control Risks for Life Sciences, Research Institutes and Universities -...

Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more

Morgan Lewis

EU Imposes Authorization Requirements for COVID-19 Vaccine Exports

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In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force...more

Hogan Lovells

UK post-Brexit regulation of medicines from 1 January 2021

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more

MoFo Life Sciences

China Technology Export Update: Amendment Of The Export Technology Catalog

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On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or...more

International Lawyers Network

Patent Disputes in Life Sciences

Having vast expertise in providing legal protection to large Russian and international pharmaceuticals and healthcare companies, Lidings has put together a Legal Digest highlighting the most notable patents disputes in Life...more

White & Case LLP

COVID-19: Summary of Legal Measures in Russia

White & Case LLP on

This summary is intended to help clients navigate the large number of legal measures taken expeditiously by the Russian authorities in connection with the spread of COVID-19. The summary is not exhaustive. It includes only...more

McDermott Will & Emery

[Webinar] Critical Business Considerations for Life Sciences and Medical Device Companies Amid the COVID-19 Pandemic - April 17th,...

McDermott Will & Emery on

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

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The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

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Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Emery on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

Morgan Lewis

Impact of Chinese Government Restructuring on the Life Sciences Industry

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On March 17, 2018, China’s National People’s Congress (NPC) approved a general plan proposed by China’s State Council to restructure certain Chinese government agencies. This restructuring plan affects a wide range of Chinese...more

Smart & Biggar

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Arnall Golden Gregory LLP

United Medical Instruments Inc. Settles Potential Civil Liability for Alleged Violations of the Iranian Transactions and Sanctions...

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

Arnall Golden Gregory LLP

Update on Life Sciences Exports to Iran and Sudan

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

Arnall Golden Gregory LLP

Every U.S. Life Sciences Company Needs an Export Control Compliance Program (No, Really….)

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

Arnall Golden Gregory LLP

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Bennett Jones LLP

Doing Business in Canada: Technology

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Many Canadian businesses are involved in researching and developing cutting-edge technology in a number of areas including: information technology, high-tech, life sciences, pharmaceuticals, clean technology, environmental...more

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