November 2023

On October 19, 2023, China’s National Medical Products Administration (“NMPA”) published the Rules for Applicable Discretion of Administrative Penalties in Drug Supervision and Administration (the “Proposed Rules”) for public comment. The Proposed Rules largely retain the overall structure of the 2012 Rules for the Applicable Discretion of Administrative Penalties in Drugs and Medical Devices (the

On November 16, 2023, the Federal Trade Commission (the “FTC”) announced a competition seeking solutions to protect consumers from voice cloning technology harms. Voice cloning technology can create a nearly identical clone of someone’s voice based on a short audio clip and is becoming more sophisticated as text-to-speech AI advances. The FTC cited concerns about

Recently, a bipartisan group of U.S. senators introduced new legislation to address transparency and accountability for artificial intelligence (AI) systems, including those deployed for certain “critical impact” use cases. While many other targeted, bipartisan AI bills have been introduced in both chambers of Congress, this bill appears to be one of the first to propose

The German government is discussing a new Pharma Strategy with a number of reforms to improve the conditions for the pharmaceutical industry in Germany. Recently, the “Strategy Paper 4.0 – Improving the General Conditions for the Pharmaceutical Sector in Germany” (original title: Strategiepapier 4.0: Verbesserung der Rahmenbedingungen für den Pharmabereich in Deutschland – Handlungskonzepte für

On November 16, 2023, the European Data Protection Board (“EDPB”) issued draft Guidelines 2/2023 on Technical Scope of Art. 5(3) of ePrivacy Directive (“Guidelines”).  Article 5(3) is the provision that requires consent before storing or accessing information on an end user’s device. Over the years it has become known as the “cookie rule,” but it

Last week, the U.S. Department of the Treasury (Treasury) and Internal Revenue Service (IRS) released a notice of proposed rulemaking (NPRM) that modifies the regulations applicable to the Energy Credit under Section 48 of the Internal Revenue Code (Code).  The NPRM also withdraws and repurposes portions of an August proposal on the rules governing the

On October 24, a Nevada federal court dismissed a class action complaint against operators of hotels on the Las Vegas Strip alleging that defendants’ use of similar room-pricing algorithms constituted a per se illegal price-fixing agreement under Section 1 of the Sherman Act.  The decision, Gibson v. MGM Resorts International, No. 2:23-cv-00140 (D. Nev. 2023),

EU advocate general Collins has reiterated that individuals’ right to claim compensation for harm caused by GDPR breaches requires proof of “actual damage suffered” as a result of the breach, and “clear and precise evidence” of such damage – mere hypothetical harms or discomfort are insufficient. The advocate general also found that unauthorised access to