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
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more
With the sudden change in the Democratic presidential candidate, there are a whole host of implications for the future of America. As presumptive nominee Kamala Harris ramps up her campaign for the White House, we examine her...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
Virginia’s HSA 1 Pharmaceutical Processor Permit - Effective January 1, 2024, the Virginia Cannabis Control Authority (CCA) assumed regulatory oversight of Virginia’s medical cannabis program. The CCA was established in...more
The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When...more
In the ever-evolving landscape of medical innovation, the journey to bring breakthrough therapies to those in need is often fraught with obstacles and red tape. For many patients grappling with life-threatening conditions,...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we note the likely end of two Wyoming ballot initiatives. Then, we have an update on the Eastern Band of...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we see Georgia pharmacies selling medical marijuana. We have an update on the Ohio legalization ballot...more
On October 2, the Virginia Board of Pharmacy posted a general notice indicating that it had voted to rescind the request for applications (RFA) for a Pharmaceutical Processor license in Health Service Area I. The RFA will now...more
Now that the dust is starting to settle on the recent news that the U.S. Department of Health and Human Services (HHS) has recommended to the U.S. Drug Enforcement Agency (DEA) that marijuana be moved from Schedule I to...more
According to a report from the Congressional Research Service (the Report), the Drug Enforcement Administration (DEA) is likely to follow the Department of Health and Human Services (HHS) and the Food and Drug...more
Just as we did, the Food and Drug Administration has recognized the growing enthusiasm for exploring opportunities to use psychedelic medications to treat mental health disorders. In June, FDA issued for the first time draft...more
In October of 2022, the Biden Administration started an official cannabis policy review process, which began with granting pardons to all people convicted of simple cannabis possession under federal law. At the time, this was...more
On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more
Introduction- The International Narcotics Control Board (“INCB”) released its “Report of the International Narcotics Control Board for 2022 (E/INCB/2022/1)” (the “Report”), which dedicates an entire section to discussing the...more
Medical Cannabis in the DMV Continuing this year’s trend of increased access to legal cannabis in the Maryland, DC and Virginia area that started with Maryland adding legalization to the ballot in November, DC and Virginia...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food,...more
With much of the cannabis oriented media focusing on the flurry of adult use bills and opportunities, it is easy to overlook that many states are doubling down on their medical marijuana infrastructure. For instance, over...more
With the ever-increasing acceptance of marijuana as a legitimate treatment for a number of medical conditions, a newfound interest in the use of psychedelics as a form of medical treatment is gaining traction once again. ...more
The 2020 Legislative Session will begin its 60-day trek to completion on Tuesday, January 14, 2020. The following is a sample of bills that have been filed. We encourage you to review these bills, and contact us with specific...more
2019 AG Elections- Republican Primary for Mississippi Attorney General Heads to Runoff; Winner Will Face Democrat Jennifer Riley Collins- None of the three Republican candidates for AG received a majority of the vote in...more
This week in Washington: Senate to hold hearings on the enforcement of antitrust laws and elder justice, while the House plans to hold a member day hearing and examine the Social Security 2100 Act....more
The German Constitutional Court and the German Highest Federal Administrative Court first introduced the concept of legal pharmaceutical-grade cannabis in 1999 and 2005, and the German legal regime has since made significant...more