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
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 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
Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...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
The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
NIST has now finalized its guidance providing important information on selecting both security and privacy control baselines for the Federal Government. The guidance is available here: Special Publication 800-53B, Control...more
Both the Commodity Futures Trading Commission and the Chicago Mercantile Exchange brought and settled charges against a CFTC-registered floor broker, claiming he engaged in spoofing trading activity on the CME. The two...more
The Department of Defense (DOD) and its component services and agencies are taking several independent steps to assess and enhance their cyber and supply chain security that will directly or indirectly affect DOD contractors...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
In October of 2011, the U.S. Securities and Exchange Commission (“SEC”) issued guidance regarding a public company’s obligations to disclose cybersecurity risks and cyber incidents (the “Cybersecurity Disclosure Guidance”)....more
Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more
On June 19, 2015, the National Institute of Standards and Technology (NIST) published the final version of guidance for federal agencies to ensure sensitive information remains confidential when stored outside of federal...more
Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more
Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more
On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more
In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more