SEC Activity with Fixed Income and Credit Funds
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
On July 30, the US Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT), a new science-based tool designed to screen and evaluate the safety or toxicity of chemicals in food....more
A new era of AI legislation has begun as the EU AI Act enters into force on August 1, 2024. With broad extraterritorial reach, significant penalties of up to seven percent of worldwide annual turnover, and an emphasis on...more
After three years of legislative debate, the Council of the European Union cast its final vote on the European Union (EU) Artificial Intelligence (AI) Act on 21 May 2024. Once published in the EU Official Journal in June, the...more
In December 2023, European Union (EU) lawmakers reached an agreement on the EU AI Act. In our article titled An Introduction to the EU AI Act, we focused on applicability, thresholds, timing, and penalties related to the EU...more
Who will play the leading role if we make a new series about AI? If you interview Steven Spielberg, Sundar Pichai, and Sam Altman, you might receive three distinct ideas ranging from the 2001 classic "AI: Artificial...more
On March 13, 2024, the EU AI Act received its final assent from the EU Parliament with 523 votes in favor, 46 against and 49 abstentions, bringing it one step closer to adoption. Minor linguistic changes are still to be...more
The Basel Committee on Banking Supervision (Basel Committee), a committee of global central bankers and regulators, issued a Consultative Document on June 10 on the prudential treatment of cryptoasset exposures for...more
The Financial Action Task Force is seeking feedback from private sector stakeholders on its draft guidance on the use of digital identity systems in customer due diligence. The guidance will supplement Recommendation 10 of...more
On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more
Established in 2003, the Basel Institute is a not-for-profit Swiss foundation dedicated to working with public and private partners around the world to prevent and combat corruption, and is an Associated Institute of the...more
Our Insurance Horizons 2018 brochure considers the impact of technology, interest rates, protectionism, excess capacity in the reinsurance market and cyber risk. We also look in detail at M&A in the industry, sanctions and...more
Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance...more
It’s not just your taxes that are due each year on April 15. For financial institutions, this coming April 15 is the date the New York Department of Financial Services’ (NYDFS’s ) new Anti-Money Laundering (AML) Part 504...more
Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more