Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Wiley Webinar: Biotech Briefings – Interim Update on Regulatory Developments Relevant to Plant Biostimulants
Edible Bites Episode 2: Cannabis and Life Sciences Video Webinar Series
As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more
1. Bank regulation - 1.1 PRUDENTIAL REGULATION - a) General - (i) International - FSB: Plenary December 2024 - Status: Final - The FSB has set out the outcomes of its Plenary that met on 3 and 4 December. Points of...more
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more
The European Banking Authority has finalized two sets of guidelines setting common standards on the governance arrangements and the policies, procedures, and controls that financial institutions should have in place to be...more
Over one year ago, on October 3, 2023, the Federal Deposit Insurance Corporation (FDIC) proposed supervisory guidelines that would establish standards for corporate governance and risk management for all state non-member...more
It is no secret that the Federal Reserve, the FDIC, and the OCC have zeroed in on banks' use of third parties for products, services, and other operations, the risks those arrangements may pose, and banks' responsibility to...more
On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more
The Situation: In October 2023, the Office of the Comptroller of the Currency ("OCC"), Federal Reserve System, and Federal Deposit Insurance Corporation ("FDIC," and the three agencies collectively, "Agencies") finalized...more
On October 24, 2023, the Federal Reserve (Fed), Federal Deposit Insurance Corporation (FDIC), and Office of the Comptroller of the Currency (OCC) issued the joint agency climate-related financial risk management guidance for...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
On June 6, 2023, the Board of Governors of the Federal Reserve System (the Federal Reserve), the Federal Deposit Insurance Corporation (FDIC) and the Office of the Comptroller of the Currency (OCC, and collectively with the...more
On June 6, 2023, the Federal Reserve Board of Governors, Federal Deposit Insurance Corporation, and the Office of the Comptroller of the Currency jointly issued final third-party risk management guidance for supervised...more
The Federal Reserve, FDIC, and OCC have released final interagency guidance for their respective supervised banking organizations on managing risks associated with third-party relationships, including relationships with...more
Financial technology companies (fintechs) and other third parties in bank partnerships are routinely subject to scrutiny by their banking partner customers. The Federal Reserve System, the Federal Deposit Insurance...more
On June 6, 2023, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation, and the Office of the Comptroller of the Currency jointly released final guidance on managing risks associated...more
The Board of Governors of the Federal Reserve System (the Board), on August 15, 2022, issued final guidelines for regional Federal Reserve Banks to use when considering applications for Federal Reserve “master...more
The global central bank cooperative body would bring stablecoins within the international standards for payment, clearing, and settlement systems....more
On November 15, 2021, the New York Department of Financial Services (NYDFS) finalized guidance, originally proposed in March 2021, on how New York-domestic insurers should manage climate change risk. See, Guidance for New...more
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information...more
It has come to our attention that some examiners have recently been carefully scrutinizing financial institutions’ employee compensation arrangements. Although it now appears unlikely that the proposed Dodd-Frank rules on...more
On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more
Of critical importance for any financial institution using Twitter or other social media for business marketing and promoting purposes, the Federal Financial Institutions Examination Council (FFIEC) has issued final...more