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
To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...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
Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more
In February 2024, the U.S. Food and Drug Administration (FDA) published its finalized guidance concerning its investigational drug charging regulations (found at 21 C.F.R. § 312.8). These regulations are applicable to...more
This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...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
On September 18, 2023, the Florida Office of Insurance Regulation (“OIR”) published proposed rules to implement provisions of the Prescription Drug Reform Act (Florida Senate Bill 1550) governing Pharmacy Benefit Managers...more
The Florida legislature took aim at pharmacy benefit managers (PBMs) during the 2023 legislative session by enacting the Prescription Drug Reform Act, Chapter 2023-29, Laws of Florida (https://laws.flrules.org/2023/29) (the...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medical devices. The Spanish Health Act gives the authorities control over health advertising. In particular, Article 102...more
For life sciences companies, Brazil’s market offers both an abundance of business opportunities and a myriad of on-the-ground regulatory compliance challenges for new entrants. Getting the market-entry strategy right will...more
The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more
As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more
The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more
Effective March 11, 2022, Ohio Board of Pharmacy (“Board”) enacted a new regulation, Ohio Admin. Code 4729:5-3-20, that creates a procedure for licensees to petition the Board for approval of pilot or research projects...more
The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more
Update: The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred, once again, until July 1, 2022. Read more on the statement from...more
The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals. A 10-week consultation launched by the UK’s Medicines...more
Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...more