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
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...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 U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
The United States Equal Employment Opportunity (“EEOC”) has issued its final guidance on “Enforcement Guidance on Harassment in the Workplace,” the first of its kind in over 20 years. This final guidance builds on a variety...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
Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more
On July 26, 2019, the IRS announced that it has begun to send letters to more than 10,000 taxpayers who might have failed to report income and pay the resulting tax from virtual currency transactions or who did not report...more
Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s...more
As of August 19, 2015, full enforcement of a recent Administrative Appeals Office (AAO) decision in Matter of Simeio Solutions, LLC, 26 I&N Dec. 542 (AAO 2015) will commence. On April 9, 2015, the AAO—the appellate body...more