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Multinationals Food and Drug Administration (FDA)

American Conference Institute (ACI)

[Event] West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products - October 8th - 9th, Santa...

ACI’s 3rd Annual West Coast Legal, Regulatory and Compliance Forum on Cosmetics & Personal Care Product is the must-attend event for cosmetics and personal care professionals looking to navigate the toughest legal,...more

Fish & Richardson

Federal Circuit Clarifies Venue in Hatch-Waxman Actions in Celgene v. Mylan

Fish & Richardson on

The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more

Haug Partners LLP

Global Developments and Considerations for Registering Cannabis and Cannabis-Related Trademarks

Haug Partners LLP on

This article discusses the global developments for the registration of cannabis and cannabis-related trademarks in the United States, Canada, Mexico, and the European Union....more

Smart & Biggar

Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

Smart & Biggar on

On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more

Cozen O'Connor

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Cozen O'Connor on

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

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