Morgan Lewis

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data have…more
| Science, Computers, & Technology

Landmark Trade Secret Law Establishes New Rights and Remedies

The Defend Trade Secrets Act of 2016 aims to modernize and strengthen trade secret law. The most significant trade secret reform in decades is about to become law. The Defend Trade Secrets Act of 2016 (DTSA) will modernize…more
| Civil Procedure, Civil Remedies, Commercial Law & Contracts, Elections & Politics, Intellectual Property

New Examples of Program-Related Investments

The new examples describe additional charitable purposes and PRI terms and structures. On April 21, the Internal Revenue Service and Treasury Department issued final regulations regarding program-related investments (PRIs)…more
| Business Organizations, Taxation

New Kazakhstan Law on Legal Acts

The new law regulates issues relating to hierarchy, legal force, and interpretation of legislative acts. On 19 April, a new law on legal acts took effect in Kazakhstan. The new law repealed the previous law on regulatory…more
| Elections & Politics, International Law & Trade

Department of State Releases May 2016 Visa Bulletin

A new geographic sector that includes El Salvador, Guatemala, and Honduras has been added. The US Department of State (DOS) has released its May 2016 Visa Bulletin. The Visa Bulletin sets out per-country priority date…more
| Immigration Law

FSMA Final Rule Published on Sanitary Transportation of Human and Animal Food

The Final Rule contains notable changes from what was originally proposed. The US Food and Drug Administration (FDA) published its final rule earlier this month regarding Sanitary Transportation of Human and Animal Food…more
| Agriculture, Transportation

US Supreme Court Hears Oral Argument on Viability of FCA’s Implied Certification Theory

In qui tam case, Supreme Court oral argument addresses practical implications of limiting the scope of the implied certification theory of liability under the FCA…more
| Civil Procedure, Government Contracting, Health

FTC Creates Web-Based Tool for Mobile Health App Developers

The new interactive tool highlights the relevant federal regulatory schemes, but the high-level analysis may limit its value to mobile health app developers…more
| Antitrust & Trade Regulation, Health

FDA Active on the Device Front for Q1 2016

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological Health…more
| Health, Science, Computers, & Technology

Corporate Tax Reform Proposal Would Raise Taxes on Exempts

Legislation could impose new taxes on dividend and interest income of tax-exempt entities. The Senate Finance Committee is reportedly formulating a legislative proposal to integrate the corporate and individual tax systems…more
| Business Organizations, Elections & Politics, Nonprofit Law, Taxation

Private Placements and the Qualifying Private Placement Exemption

The new exemption from UK withholding tax will affect certain debt finance arrangements and the issuance of debt securities between foreign lenders or investors and UK corporate borrowers or issuers that operate in private…more
| Business Organizations, Finance & Banking, International Law & Trade, Taxation

Article 29 Working Party Expresses Concerns About EU-US Privacy Shield

European Commission may need to revise the draft proposal to meet the concerns expressed by the Article 29 Working Party. As we reported in a previous LawFlash (European Commission Releases Details of New EU-US Privacy…more
| International Law & Trade, Privacy, Science, Computers, & Technology

Pennsylvania Governor Signs Sexual Orientation Nondiscrimination Orders

Protection from discrimination based on sexual orientation is now expanded to government contractors and government employees. On April 7, Pennsylvania Governor Tom Wolf signed two executive orders. The first order bars…more
| Civil Rights, Labor & Employment Law

Potential Commercial Litigation Consequences of 'Brexit'

With the referendum for Britain potentially leaving the European Union (“Brexit”) fast approaching on 23 June 2016, a “leave” vote could have far-reaching consequences for commercial litigation in the courts of England and…more
| Civil Procedure, Commercial Law & Contracts, Business Torts, International Law & Trade

Final DOL Fiduciary Rule—First Impressions

Final rule includes many changes and clarifications intended to address concerns raised about the proposal, but issues remain. The US Department of Labor (DOL) has released its final regulation “Definition of the Term…more
| Finance & Banking, Labor & Employment Law
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