Morgan Lewis

FDA Issues Final Rules That Change Nutrition Facts Labels

No more sugar coating—the Rules impose new label requirements, and manufacturers will incur additional costs. The US Food and Drug Administration (FDA or the Agency) has announced the issuance of two new final rules: one on…more
| Consumer Protection, Products Liability

Second Circuit Highlights Splits on Nominative Trademark Fair Use

The Second Circuit disagrees with sister circuits and rejects arguments that nominative fair use is an affirmative defense that is available even when confusion is likely and that the traditional nominative fair use analysis…more
| Civil Procedure, Communications & Media Law, Intellectual Property

Potential Impact of ‘Brexit’ on Arbitration

As we stand only weeks away from the United Kingdom’s referendum on a potential cleaving from the European Union, economists and politicians are busy analyzing the potential effects of either decision; there are also potential…more
| Alternative Dispute Resolution (ADR), Commercial Law & Contracts, Elections & Politics, International Law & Trade

FERC Upholds and Clarifies Reforms to Market-Based Rate Program

The clarifications address concerns from market participants but leave some questions unanswered. On May 19, the Federal Energy Regulatory Commission (FERC or the Commission) issued Order No. 816-A, which upholds and…more
| Commercial Law & Contracts, Energy & Utilities

Update: Midland Funding v. Madden

In an amicus curiae brief, the US Solicitor General recommends that the petition for certiorari in Madden be denied, but agrees that the Second Circuit’s decision is incorrect and emphasizes the importance of banks being able to…more
| Civil Procedure, Commercial Law & Contracts, Conflict of Laws, Consumer Protection, Finance & Banking

CFTC Proposes to Allow Private Lawsuits for Transactions in RTOs and ISOs

The proposal could create uncertainty for market participants and raise jurisdictional questions about which regulator should police power markets…more
| Civil Procedure, Energy & Utilities, Finance & Banking, Securities Law

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the…more
| Health, Privacy, Science, Computers, & Technology

FERC Finalizes Hold-Harmless Policy and Strikes the Most Problematic Proposals

FERC guidance clarifies the scope of the hold-harmless commitments offered in electric utility mergers and acquisitions, but discards its initial proposal to make those commitments open-ended. On May 19, the Federal Energy…more
| Commercial Law & Contracts, Energy & Utilities, Mergers & Acquisitions

IRS Offers Tax Guidance Relating to Money Market Fund Rules

The IRS recently provided relief from the RIC distribution requirement for money market funds that receive contributions in connection with the transition to a floating NAV, enabling RICs to top up their NAVs without having to…more
| Commercial Law & Contracts, Finance & Banking, Insurance, Securities Law, Taxation

ISO 37001: A New Measuring Stick for Corporate Compliance Programs

The International Organization for Standardization is developing a certifiable international standard for “anti-bribery management systems” that could influence how the US Department of Justice, US Securities and Exchange…more
| Business Organizations, Commercial Law & Contracts, Criminal Law, International Law & Trade, Securities Law

Singapore Bond Market: Issuing Retail Bonds without a Prospectus

New regulations facilitate retail investor participation in the Singapore bond market. On May 19, the Monetary Authority of Singapore (MAS) promulgated two new regulations, effective immediately, to facilitate retail…more
| Business Organizations, Commercial Law & Contracts, Finance & Banking, International Law & Trade, Securities Law

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or Agency)…more
| Administrative Law, Health, Science, Computers, & Technology

DOL Updates FLSA Overtime Exemption Regulations

The update significantly increases the salary level needed to qualify as exempt under the FLSA’s white collar and highly compensated exemptions…more
| Labor & Employment Law

Supreme Court Issues Closely Watched Article III Standing Decision

The Court holds that allegation of a statutory violation is not solely sufficient to satisfy the “concrete harm” requirement for purposes of Article III standing in federal court…more
| Civil Procedure, Civil Remedies, Constitutional Law, Consumer Protection

New SEC Guidance on Non-GAAP Financial Measures Will Require Changes to Many Non-GAAP Presentations

On May 17, the SEC’s Division of Corporation Finance issued new and revised Compliance & Disclosure Interpretations (CDIs) on the use of non-GAAP financial measures. These CDIs will likely affect many non-GAAP financial measure…more
| Business Organizations, Securities Law
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