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
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more
On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more
The firm is pleased to present the latest edition of The Life Sciences Report. This issue features a sampling of recent COVID-19-related client activity in which the firm has been involved, an article on life sciences venture...more
Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of...more
On December 2, 2020, the U.K. became the first Western nation to approve the use of Pfizer/BioNTech’s COVID-19 (SARS-CoV-2) vaccine for mass inoculation. As pressure mounts on U.S. regulators to follow suit, the next 30 days...more
Because they are made up of human beings, they are imperfect organizations. But for decades, the federal Centers for Disease Control and Prevention (CDC) and the federal Food and Drug Administration (FDA) have won global...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more
2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices,...more
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more
The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special...more
The blame and shame for the opioid-drug overdose crisis that kills tens of thousands Americans annually has moved to yet another set of individuals and institutions now — judges and courts that handled Big Pharma lawsuits and...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
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety,...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
On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more
Drug Manufacturing is Big Business - The Food and Drug Administration (FDA) has the responsibility to protect the health of U.S. consumers by ensuring food, drugs and medical devices are safe. The FDA also has a mission to...more
On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more
The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more