Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
Innovation in Compliance: Innovative Approaches to Compliance and Training with Catherine Choe
Innovation in Compliance: Exploring the Fractional COO Model with La Tonya Roberts
Innovation in Compliance: Design-Centric Compliance Training with Karen Oddo
Innovation in Compliance: Strategic Compliance in Regulated Industries with Kerri Reuter
Cannabis Law Now Podcast - From Law Firm to Board Room: The Journey of a Cannabis Entrepreneur
Innovation in Compliance: The Strength Trap: When Being the Strong One Starts Breaking You – Part 2: Tactical Resilience: Mastering Stress and Self-Awareness
Innovation in Compliance: The Strength Trap: When Being the Strong One Starts Breaking You – Part 1: Understanding the Hidden Costs of High-Stress Professions
Innovations in Compliance: Data Collection & Cybersecurity with ModeOne’s Matt Rasmussen and Ryan Frye
Compliance and AI: Harnessing AI and Innovation: A Deep Dive into Compliance and Disruption with Jag Lamba
Taking the Pulse, A Health Care and Life Sciences Video Podcast | SCbio 2025 Preview with President & CEO James Chappell
Approach to Responsible AI
Bridging the Gap: How CivicReach is Revolutionizing Government Customer Service
Episode 354 -- The New Era of Compliance: Generative AI, Data and Innovation
The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 212: Fujifilm’s Investment in North Carolina with Christine Vannais and Laurie Braxton of Fujifilm
Defense Dynamics: Navigating the Post-Election Landscape for the National Security Sector
Hosted Payload S2.E1: Caroline Van Wie/Working Girl
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Following the announcement that four Center for Medicare and Medicaid Innovation (CMMI or Innovation Center) models will end in 2025, the Centers for Medicare & Medicaid Services (CMS) has begun signaling what's next for the...more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more
On January 4, 2021, the National Institute of Standards and Technology (NIST) published proposed rules for comment changing regulations promulgated under the Bayh-Dole Act (35 U.S.C. §§ 200-204), which allow businesses and...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more
Building on the momentum of early October hearings on the state’s growing health care expenditures, the Health Policy Commission (HPC), the Joint Committee on Health Care Financing, Governor Charlie Baker, and others spent...more