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
Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more
If a picture is worth a thousand words, what’s a video worth? Pharmaceutical companies invest heavily in online advertisements and product websites to explain their prescription medications’ uses, benefits, and risks. The...more
The December 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses new enforcement tools courtesy of the Trademark Modernization Act; Pfizer's acquisition of Arena Pharmaceuticals; the latest developments in...more
Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more
If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. More accurately, the FDA has its eye on your website and social media, checking to see what you’re claiming...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Social media influencers have become the latest source of health information for many. This is especially true right now, amidst the ongoing and rapidly evolving COVID-19 pandemic....more
The widespread use of social media platforms make them ideal for companies trying to reach a large audience. Pharmaceutical and consumer products industries frequently maintain their own social media accounts and partner with...more
To help identify trends in privacy representations, BCLP reviewed the websites and privacy notices of each pharmaceutical company listed within the Fortune 500. The following summarizes current industry trends...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
In a recent decision under the Uniform Domain Name Dispute Resolution Policy (UDRP) before the World Intellectual Property Organization (WIPO), a Panel denied the transfer of a domain name because the Complainant failed to...more
CARTELS & RESTRICTIVE AGREEMENTS - CJEU’S EYE-OPENING RULING ON ANTITRUST COMPLIANCE AND OFF-LABEL MISINFORMATION – C 179/16, HOFFMAN-LA ROCHE AND OTHERS V AGCM, 23 JANUARY 2018 – On 23 January 2018, the CJEU...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
The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more
For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more
Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more
Current law permits a hospital, health system, or medical school to organize and become a member of a medical foundation, which can practice medicine through its employees or agents who are physicians, chiropractors,...more
Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more
The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual...more
Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more
Many Canadian businesses are involved in researching and developing cutting-edge technology in a number of areas including: information technology, high-tech, life sciences, pharmaceuticals, clean technology, environmental...more