Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast - Discussing the Mission of Black Women's Health Imperative with CEO Linda Goler Blount
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
BLACK HISTORY MONTH | KATHERINE JOHNSON AND CHARLES DREW
Technology in Healthcare
The 2024 Public Health Service (PHS) Policies on Research Misconduct involving PHS-funded research were released by the U.S. Department of Health and Human Services (HHS) through the Office of Research Integrity (ORI) on...more
On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more
On September 12, 2024, the federal Office of Research Integrity (ORI) announced the release of the Department of Health & Human Services’ Final Rule on Public Health Service Policies on Research Misconduct. This marks the...more
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
With the advancement in modern medicine, people are living longer than ever. In fact, the average life expectancy has largely risen over the last 40 years, and is predicted to rise to 85 by the year 2060 (US Census:...more
Traumatic brain injury (TBI) is a leading cause of death and disability worldwide, often leading to posttraumatic seizures (PTS) which can exacerbate brain damage, increase hospital stays, and worsen functional outcomes....more
As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more
For our 200th episode, we are thrilled to welcome University of South Carolina Women’s Basketball Coach and Olympic Gold Medalist Dawn Staley back to the podcast! Fresh off the 2024 National Championship, Coach Staley shares...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...more
Deal volume across the healthcare industry generally appears to have steadied despite headwinds. The general sentiment is that buyers have adapted to the current interest rates and are gritting their teeth and pressing...more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
On April 30, 2024, the Associated Press reported a significant development in cannabis policy: the U.S. Drug Enforcement Administration (“DEA”) is recommending reclassifying cannabis from Schedule I to Schedule III. This...more
For centuries, humans have sought ways to protect from deadly diseases. The practice of intentionally exposing healthy people to smallpox, a practice known as variolation, likely began as early as 200 BCE. ...more
In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...more
Inspired by renowned medical districts in the nation’s greatest cities, Tampa General Hospital and USF Health Morsani College of Medicine have partnered with the Tampa Bay Economic Development Council to create a life...more
New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more
The United States occupies a leadership position in clinical advancements, in terms of pharmaceuticals, medical devices, innovative care processes and interventional techniques. At the nexus of these advances are clinical...more
In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more
New, or newly interpreted, state laws and court decisions governing abortion may directly affect access to medical care and treatment for patients who are, or who want to become, pregnant. They also have potential...more
After 50 years of being on the most restrictive schedule alongside drugs like heroin and PCP, the DEA will move to reschedule marijuana in Schedule III, where the plant’s medical benefits will finally be recognized by the...more
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more