Ropes & Gray LLP

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Boston, MA 02199-3600, United States

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FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a…more
| Administrative Law, Health, Science, Computers, & Technology

FDA Releases Long-Awaited LDT Regulatory Framework and Finalizes Companion Diagnostics Guidance

On July 31, 2014, the Food and Drug Administration (FDA) took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices (IVDs). First, FDA released its long-awaited plan for…more
| Administrative Law, Health, Science, Computers, & Technology

SEC Adopts Reforms for Money Market Funds

On July 23, 2014, the Securities and Exchange Commission (the “SEC”) voted three-to-two to adopt significant new reforms for money market funds (“MMFs”) (the “Final Rule”). The reforms are intended to reduce the susceptibility…more
| Commercial Law & Contracts, Finance & Banking, Securities Law

China Unveils Detailed Rules to Implement the Core Device Regulation

The amended Regulation for the Supervision and Administration of Medical Devices (the “Regulation,” also known as the State Council Order No. 650), which came into force on June 1, 2014, set the new framework for China’s device…more
| Health, Science, Computers, & Technology

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating…more
| Administrative Law, Health, Science, Computers, & Technology

SEC Charges Corporate Officers with Fraud Arising from Failure to Disclose Internal Controls Issues and Alleged Misrepresentations in SOX Certifications

On July 30, 2014, the Securities and Exchange Commission (“SEC”) advanced a novel theory of fraud against the former CEO (Marc Sherman) and CFO (Edward Cummings) of Quality Services Group, Inc. (“QSGI”), a Florida-based computer…more
| Commercial Law & Contracts, Finance & Banking, Business Torts, Securities Law

Implications of the Argentina Debt Litigation for Foreign Sovereign Immunity

Foreign sovereigns have long assumed that the Foreign Sovereign Immunities Act (FSIA) provides them with substantial protection against litigants in United States courts. Although the immunity afforded by the FSIA has never been…more
| Civil Procedure, Civil Remedies, Finance & Banking, International Law & Trade

D.C. Circuit Issues Ruling in Important CFIUS Case

The D.C. Court of Appeals recently issued a landmark decision in Ralls Corporation v. Committee on Foreign Investment in the United States (CFIUS), No. 13-5315, slip. op. (D.C. Cir. July 15, 2014), that could have far-reaching…more
| Civil Procedure, Constitutional Law, Elections & Politics, Finance & Banking, International Law & Trade

New Credit Default Swap Terms to Be Implemented in September 2014

Earlier this year, the International Swaps and Derivatives Association Inc. (ISDA) published the 2014 Credit Derivatives Definitions (the 2014 Definitions). The 2014 Definitions introduce a new government bail-in Credit Event…more
| Commercial Law & Contracts, Finance & Banking, International Law & Trade, Securities Law

The Ropes Recap: Mergers & Acquisition Law News - Second Quarter 2014

In this issue: -Delaware Legislative Update -Delaware Supreme Court Upholds Facial Validity of Fee-Shifting Provisions in Bylaws of Delaware Non-Stock Corporation -News from the Courts: -Court of…more
| Civil Procedure, Commercial Law & Contracts, Mergers & Acquisitions, Securities Law, Taxation

Ongoing Obligations Under AIFMD for Non-EEA Private Fund Managers – Regulatory Reporting, Annual Investor Report and Investor Disclosures

The Alternative Investment Fund Managers Directive (the “AIFMD”) introduces new requirements for alternative investment fund managers (“AIFMs”) established in the European Economic Area (“EEA”) and non-EEA AIFMs that market…more
| Commercial Law & Contracts, Finance & Banking, International Law & Trade, Securities Law

Third Circuit Holds Ambiguous Contract Precludes FCA Liability

The Third Circuit recently upheld summary judgment in favor of the defendant in U.S. Dept. of Transp. ex rel. Arnold v. CMC Engineering, a whistleblower suit alleging the defendant overbilled Pennsylvania’s Department of…more
| Civil Procedure, Labor & Employment Law, Transportation

CMS Releases Proposed 2015 Physician Fee Schedule and Outpatient Prospective Payment System Rules

On July 3, 2014, the Centers for Medicare and Medicaid Services (“CMS”) released its proposed Calendar Year (“CY”) 2015 Physician Fee Schedule (“PFS”) Proposed Rule, to be published in the Federal Register on July 11, 2014. The…more
| Health, Science, Computers, & Technology

Recent SCOTUS Decisions in Intellectual Property Cases

The U.S. Supreme Court heard a landmark number of intellectual property cases during its 2013-2014 term. Below is a summary of recent decisions issued in 2014…more
| Civil Procedure, Civil Remedies, Communications & Media Law, Intellectual Property, Science, Computers, & Technology

Supreme Court to Decide Important False Claims Act Statute of Limitations and Jurisdictional Bar Issues

On July 1, 2014, the Supreme Court granted certiorari in Kellogg Brown & Root Services, Inc., et al. v. United States ex rel. Carter (No. 12-1497), a case involving two issues that have been central to recent False Claims Act…more
| Civil Procedure, Government Contracting
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