False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more
The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the...more
Legislation - Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs - During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved...more
As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more
The Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) jointly sent warning letters on April 3, 2019 to companies that advertise and sell cannabidiol (CBD) containing products via internet...more
Food/Dietary Supplements - FDA Commissioner Announces Ongoing Services During the Partial Government Shutdown – The FDA released a statement that certain programs would continue to run during the shutdown. ...more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more
Last week, the industry was energized by the Drug Enforcement Administration’s order placing certain drugs containing cannabidiol, or CBD, in Schedule V of the Controlled Substances Act. This marks the first time in history...more
Lawmakers have returned from the Memorial Day recess and are facing a packed legislative agenda over the summer. With the announcement this week of a shortened August recess, the Senate will have more time to address...more
Congress returned from its spring recess with a host of issues to address—trade, Trump administration nominations and opioid legislation sitting atop the priority list. Given the ongoing data scandal at Facebook, privacy...more
On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more
What's New - SENATE - It was another busy week in the Senate as members continued to work through various bills on the lengthy Senate Calendar. The Senate spent the day on Wednesday taking up the Governor’s veto on...more