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
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
Overview - The White House, through its Office of Management and Budget (OMB), has issued final Guidance for Regulation of Artificial Intelligence Applications (Guidance) which establishes a framework for federal agencies to...more
On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more
On August 25, 2016, the Federal Acquisition Regulatory Council issued final rules and the Department of Labor (DOL) published final guidance implementing President Obama’s 2014 “Fair Pay and Safe Workplaces” Executive Order...more
GOVERNMENT CONTRACTS - Fair Pay and Safe Workplaces - DOD, GSA, and NASA issued a final rule amending the FAR to implement Executive Order 13673, Fair Pay and Safe Workplaces, which is designed to increase efficiency...more
Earlier this week the Office of Federal Contract Compliance Programs (OFCCP) issued a directive to “clarify that existing agency guidance on discrimination on the basis of sex... includes discrimination on the bases of gender...more
The Office of Federal Contract Compliance Programs (OFCCP) has published a Directive on Gender Identity and Sex Discrimination (DIR 2014-02). The Directive clarifies that agency guidance on discrimination on the basis of sex...more