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
FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more
No matter what the carping critics may claim about the shortcomings of the civil justice system, when Big Tobacco, Big Pharma, and big organizations exploit and harm the vulnerable, lawsuits and what follows may provide a...more
Food - FDA Released Final Rule on Gluten-Free Labeling – The final rule establishes compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, that use the...more
This week in Washington: CMS develops additional code for coronavirus lab tests, announces actions to address spread of coronavirus; House passes bill to ban e-cigarette flavors; Grassley says updated Senate Finance drug...more
DUSTING SPRAY DEATHS AND INJURIES - Robins Kaplan LLP is investigating and litigating “dusting” cases, which arise when someone inhales—or “huffs”—compressed gas dusting spray for its intoxicating effects while driving and...more
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more
The City of London has denied Uber’s request to extend its license in the city over concerns for rider safety. The decision puts Uber’s 45,000 drivers there in limbo, though they’ll be able to continue operating while the...more
Food/Dietary Supplements - Deputy Commissioner for Policy, Legislation, and International Affairs Gives Remarks at the Food Allergy Summit – The deputy commissioner stated, “Today, allergies are a growing public health and...more
Food/Dietary Supplements - FDA Releases Final Rule on Calorie Labeling for Products in Vending Machines – The FDA stated, “The rule issued today finalizes the 2018 proposed rule and requires that the FOP calorie...more
Food/Dietary Supplements - FDA Publishes Updates to Manufacturer Food Regulatory Program – The FDA made available “revised food safety standards for state regulatory programs that oversee food facilities that manufacture,...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
There seems to be a never-ending outbreak of a certain kind of pathology in the United States. Big Pharma has it and spreads it around, a lot. So, too, do public health figures. Let’s call this scourge what it is —...more
Food/Dietary Supplements - Acting FDA Commissioner Discusses Food Safety Modernization Act (FSMA) Progress – Acting Commissioner Sharpless announced the Food Safety Dashboard as part of the FDA-TRACK, “which is one tool...more
Food/Dietary Supplements - FDA Issues Guidance on Fish and Fishery Products – The FDA released a draft guidance “intended to clarify steps that owners of fish and fishery products, or their representatives, can take to...more
Food/Dietary Supplements - FDA Issues Reminder to Firms Exporting Collagen, Gelatin or Seafood Products – The FDA reminded exporters to the European Union to use the Export Listing Module (ELM) when exporting food...more
2019 AG Elections- Lynn Fitch Secures Republican Nomination for Mississippi Attorney General in Runoff Election- Mississippi held a runoff election for the Republican AG primary race on August 27, 2019....more
Food/Dietary Supplements - States Enact Laws to Limit Use of the Term ‘Meat’ – A number of states have passed laws limiting the use of certain terms like meat, burger, etc., to describe plant-based foods, because such...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
Food/Dietary Supplements - FDA Announces Consent Decree Against Food Warehouse – A U.S. District Court in Arkansas entered a consent decree against a facility that warehoused food, drug products and medical products under...more
Antitrust- 10 Attorneys General Sue to Enjoin Merger of Major Wireless Phone Companies- 10 AGs, led by New York AG Letitia James and California AG Xavier Becerra, filed a lawsuit to enjoin T-Mobile US, Inc. and its parent...more
Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the...more
Food/Dietary Supplements - Agencies Announce Food Waste Reduction Strategy – The FDA, USDA and EPA released a food waste strategy. ...more
Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. “Ned” Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute....more
Cannabis / Marijuana- FTC and FDA Issue Warning Letters to Companies Advertising and Selling Cannabidiol Products- The Federal Trade Commission (“FTC”) and the Food & Drug Administration (“FDA”) issued warning letters to...more
FDA Acting Commissioner Announced – It has been widely reported that Ned Sharpless, director of the National Cancer Institute, will be appointed the acting commissioner of the FDA following Commissioner Gottlieb’s...more