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Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s Thanksgiving…more

Cloud Computing in the Financial Services Sector – the UK FCA Gets On-Message

It’s been a long wait but the UK’s financial services regulator, the Financial Conduct Authority (FCA), has published proposed guidance for UK-regulated financial services firms when using cloud computing solutions to implement…more

Spain issues deadline for implementing alternative Safe-Harbor mechanisms

Spain’s Data Protection Authority, the Agencia Española de Proteccion de Datós (‘AEPD’), has issued a deadline of 29 January 2016, for the implementation of alternative mechanisms to Safe Harbor…more

Manatt on Medicaid: Kentucky Update—Outgoing Governor Beshear Argues for Continuation of Medicaid Expansion and State-Based Marketplace

In an impassioned speech on November 13, 2015, outgoing Kentucky Governor Steve Beshear (D) made the case for why Governor-elect Matt Bevin should continue the healthcare reforms enacted in Kentucky under the Affordable Care Act (ACA)…more

Prior Art Enablement Looks to Applicant’s Specification to Determine Ordinary Level of Skill - In re Morsa

Addressing the issue of whether an anticipatory prior art reference was enabling, the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the U.S. Patent Trademark Office (USPTO) Board of Patent Appeals and…more

Court Report - November 2015 #6

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al. 1:15-cv-00756; filed August 27, 2015 in the District Court of…more

Energy & Environment Update - November 2015 #4

Energy and Climate Debate - Congress returns from the Thanksgiving recess early next week to a full schedule starring the six-year reauthorization of federal highway programs, which expires December 4 now that chambers passed last…more

Cyber Monday, Social Commerce and the End of an Era

Online sales on the Monday after Thanksgiving weekend—Cyber Monday—have continued to increase year over year since the day was first christened “Cyber Monday” in 2004. As social media enthusiasts, we were surprised to learn that social…more

Germany To Significantly Expand Protections for Temporary Workers

The German government’s plan to strengthen the rights of temporary workers could have far-reaching implications for companies that have any workers based in the country. The Federal Ministry for Labour and Social Affairs (the Ministry)…more

Health Alert (Australia) - November 30, 2015

In This Issue: - Judgments; Legisltation; and Reports. -Excerpt from Judgments: Queensland 9 October 2015 - Queensland Newspapers Pty Ltd v Medical Board of Australia & Bird [2015] QCAT 422 The…more

DOL’s Request for Information on Employees’ Use of Electronic Devices Expected in February 2016

In its July 2015 notice of proposed rulemaking on the forthcoming changes to the “white collar” overtime regulations, the U.S. Department of Labor (DOL) recognized employer concerns regarding the remote use of electronic devices by…more

Omnicare – It’s Not a Lie if I Believe What I Say, Right?

The Supreme Court recently grappled with the question: when can an opinion give rise to liability under Section 11 of the Securities Act of 1933 if the person speaking the opinion believes that their statement is true? Omnicare, Inc…more

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Mintz Levin has an exemplary record of success in securities litigation, derivative suits, enforement proceedings, and regulatory investigations. With a bench that includes former officials from the…

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