News & Analysis as of

Guidance Update

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

IAIS Proposes Revisions To Insurance Core Principle 13 On Reinsurance

by Carlton Fields on

The International Association of Insurance Supervisors (“IAIS”) recently released proposed revisions to the existing version of its Insurance Core Principle 13 regarding “Reinsurance and Other Forms of Risk Transfer.” The...more

DOL revises guidance regarding exercise of shareholder rights by ERISA fiduciaries

by Thompson Coburn LLP on

At the end of 2016, the U.S. Department of Labor (DOL) issued Interpretive Bulletin 2016-1 which provides updated guidance regarding fiduciary obligations with respect to corporate stock held by employee benefit plans that...more

Nutter Bank Report, May 2017

Supreme Court Rules That Cities Can Sue Lenders Under the Fair Housing Act - The U.S. Supreme Court has issued a decision that reaffirms the standing of municipalities to sue lenders, including banks, for certain...more

Corporate and Financial Weekly Digest - Volume XII, Issue 14

SEC/CORPORATE - SEC Division of Corporation Finance Provides Update on Conflict Minerals Rule - On April 7, the Securities and Exchange Commission Division of Corporation Finance (the Division) issued a statement...more

Medicare Two-Midnight Rule and Observation Status Updates

by Baker Ober Health Law on

What's new from Medicare in the areas of the Two-Midnight rule and observation services? CMS recently published updates to a Medicare manual reflecting clarifications to its Two-Midnight policy, a Medicare Quality Improvement...more

Separately Managed Accounts – SEC Provides Guidance on “Inadvertent” Custody and Reliance on Standing Letters of Authorization

by Ropes & Gray LLP on

The SEC’s Division of Investment Management recently published a three-page Guidance Update, Inadvertent Custody: Advisory Contract Versus Custodial Contract Authority (the “Guidance”). The purpose of the Guidance is to...more

The IRS Provides Updated Guidance on Hardship Distributions

by Bass, Berry & Sims PLC on

The Internal Revenue Service (IRS) recently issued updated audit guidelines for its agents regarding the substantiation requirements for hardship withdrawals from 401(k) and 403(b) plans. This guidance is welcome news for...more

DOJ and FTC Issue Updates to Antitrust Guidelines for the Licensing of Intellectual Property for the First Time Since 1995

by Miller Canfield on

For the first time, the Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) have updated the Antitrust Guidelines for the Licensing of Intellectual Property (“IP Licensing Guidelines”). First issued in...more

SEC Staff Issues Guidance Update and Investor Bulletin on “Robo-Advisers”

by Dechert LLP on

The staff of the Division of Investment Management (Staff) of the U.S. Securities and Exchange Commission (SEC) published a Guidance Update (Guidance) on February 23, 2017, on the subject of automated investment advisers...more

SEC Weighs In on Robo-Advisers: Disclosure, Suitability, and Compliance Obligations

by Morgan Lewis on

The SEC’s Guidance recognizes that robo-advisers are fiduciaries, and provides suggestions on how they can meet the substantive requirements of the Investment Advisers Act of 1940. ...more

FERC Issues Updated Guidance Manual for Environmental Report Preparation Under the Natural Gas Act

by Dorsey & Whitney LLP on

Last week, the Federal Energy Regulatory Commission (FERC) issued an update to its Guidance Manual for Environmental Report Preparation for Applications Filed Under the Natural Gas Act. The updated guidance follows a Notice...more

SEC's Division of Investment Management issues guidance for "robo-advisers" – key takeaways

by DLA Piper on

The Staff of the SEC's Division of Investment Management (IM), in conjunction with the Office of Compliance Inspections and Examinations (OCIE), has issued its second Guidance Update of 2017. [1] This Guidance focuses on...more

Facelift for Two Millennials: DOJ and FTC Update Guidelines for IP Licensing and International Enforcement

by WilmerHale on

More than 21 years ago, the US antitrust agencies issued guidance to the business community on two critical topics of antitrust enforcement: (1) the licensing of intellectual property rights and (2) international enforcement...more

A Case of Appendicitis: SEC Staff Guidance on Sales Load Variation Disclosures Sends Funds Scrambling

by Morrison & Foerster LLP on

A Guidance Update published in December 2016 by the SEC’s Division of Investment Management has sent funds scrambling to beef up prospectus disclosures to accommodate changes to fees charged by financial intermediaries before...more

DFS Announces “Updated” Cybersecurity Regulation

Yesterday, the New York Department of Financial Services (DFS) announced an “updated” cybersecurity regulation that will go into effect on March 1, 2017. The updated regulation is, in many respects, less stringent than the...more

SEC Issues Guidance on Fund Changes Intended to Simplify Compliance with the Department of Labor’s “Conflict of Interest” Rule

by Ropes & Gray LLP on

On December 15, 2016, the SEC’s Division of Investment Management issued a Guidance Update titled, Mutual Fund Fee Structures. The Guidance focuses on disclosure issues and procedural requirements arising from (i) funds...more

FDA Issues Guidance on December 28, 2016 for Postmarket Management of Cybersecurity in Medical Devices

by Tucker Arensberg, P.C. on

I am repeating the Introduction of the FDA Guidance, and attaching a link to the 30 page document. The Food and Drug Administration (FDA) is issuing this guidance to inform industry and FDA staff of the Agency’s...more

SEC Staff Issues Guidance on Fund Fee Structure Disclosures

by Dechert LLP on

In a Guidance Update published on December 15, 2016, the staff of the U.S. Securities and Exchange Commission’s (SEC) Division of Investment Management (Staff) articulated its views as to certain disclosure issues and...more

IRS Further Updates Beginning of Construction Guidance for Renewable Energy Tax Credits

On December 15, 2016, the Internal Revenue Service (IRS) issued Notice 2017-04, which updates prior guidance regarding the beginning of construction requirement for renewable energy tax credits under IRC sections 45 and 48. ...more

IRS Updates “Beginning of Construction” Guidance

by Stoel Rives LLP on

The IRS today issued highly anticipated guidance updating the “beginning of construction” requirement for the production tax credit (PTC) under Section 45 of the Internal Revenue Code (the Code) and the investment tax credit...more

The Latest Memorandum from USPTO on Subject Matter Eligibility Provides Additional Guidance for Post-Alice Prosecution

by Ward and Smith, P.A. on

On November 2, 2016, the United States Patent and Trademark Office ("USPTO") issued a memorandum to Examiners ("Memorandum") updating the USPTO's May 2016 subject matter eligibility ("SME") guidance in light of recent...more

U.S. Coast Guard Issues First Ballast Water Management System Type-Approval Certificate and New Policy Guidance

by Blank Rome LLP on

Action Item: Vessel owners and operators should re-evaluate their plans to comply with U.S. ballast water management (“BWM”) requirements in light of the U.S. Coast Guard’s type-approval of Optimarin AS’ UV-based treatment...more

Health Canada releases revised guidance on the submission requirements for biosimilar biologic drugs

by DLA Piper on

On December 2, 2016, Health Canada released the revised Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs. The Guidance is intended to assist biosimilar companies to navigate the...more

EEOC Issues Updated Guidance to Curb National Origin Discrimination

Whether you enjoyed (or not) the most recent Saturday Night Live skit where Alec Baldwin (as Trump) states he is “going to build that swamp,” the fact is that anti-immigrant rhetoric is on the rise following Trump’s promise...more

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Cybersecurity

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