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
In recent years, drug-related overdoses have become a leading cause of death during pregnancy and the postpartum period, exacerbating a mounting maternal mortality crisis and underscoring the need for improved access to care...more
Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit. The kit was developed for those who are unable to...more
Lawsuits Filed Against Tylenol, Acetaminophen Manufactures Over Autism, ADHD Link - Parents whose children were born with autism, attention deficit hyperactivity disorder (ADHD), or certain other developmental disorders...more
Depression during pregnancy, or prepartum depression, is a common condition that an estimated ten percent of women in the United States experience. The development of selective serotonin reuptake inhibitors (“SSRI”) offered...more
Prenatal vaccines provide important protection for pregnant women and newborns against communicable diseases such as whooping cough and influenza. However, fewer than one out of four pregnant women receives all federally...more
On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the...more
During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific...more
On April 7, 2023, two federal judges in Texas and Washington State issued dueling opinions about the abortion medication Mifepristone, just hours apart. These two decisions come in the midst of growing tension about abortion...more
Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge’s questions, as reported...more
The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more
In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more
Medications containing Acetaminophen are one of the most commonly used pain relievers worldwide. The chemical compound is an active ingredient in over 600 medicines. For most people, Acetaminophen is benign and can be used to...more
Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more
With healthcare playing such a central role in the election, what could the Super Tuesday results mean for healthcare stakeholders? On March 2—the day before Super Tuesday—Manatt Health will explore these questions in a new...more
The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses. The Development: The U.S. Food and Drug...more
In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and...more
Act 188 Plans On Hold as New Chemical Bill is Introduced - Nearly three years after the legislature passed a law to regulate children’s products containing chemicals of high concern, a web site intended to inform the...more
Kentucky receives final approval from CMS to transition its Marketplace to the HealthCare.gov platform; Ohio puts a prescription drug price ceiling on its November 2017 ballot; and a new study links Medicaid expansion to...more
In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL. These cases were consolidated in 2012 and involved allegations...more