Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more
5/28/2025
/ Audits ,
Best Practices ,
Clinical Trials ,
Compliance ,
Data Integrity ,
Data Management ,
Good Clinical Practices ,
Health Canada ,
Inspections ,
Regulatory Agencies ,
Risk Management ,
Standard Operating Procedures
Artificial intelligence (AI) continues to dominate headlines—not just for its technological leaps, but also for the policies shaping its future. In a major development, a new Republican-backed tax bill, released by the House...more
5/19/2025
/ Artificial Intelligence ,
Consumer Protection Laws ,
Federal Trade Commission (FTC) ,
Healthcare ,
Innovation ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform ,
State and Local Government ,
State Legislatures ,
Technology Sector
On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), challenging the FDA’s final rule...more
A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more
This post is the fifth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions. Throughout this series,...more
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more
There has been a lot of buzz around psychedelics, and particularly their potential usefulness in treating existential suffering at the end of life. Husch Blackwell was the first law firm in the country to establish a...more
On September 9, 2024, the U.S. Department of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued a Final Rule clarifying and adding additional requirements on health plans to...more
Research into psychedelic-assisted therapy receives funding in the National Defense Authorization Act for Fiscal Year 2024.
In an epoch marked by rapid innovation in mental health treatments, a paradigm shift is on the...more
Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet...more
Amid the growing interest in psychedelic-assisted psychotherapy, especially with substances like MDMA, psilocybin, and ketamine, it becomes imperative to navigate the intricate landscape of legal considerations associated...more
On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of...more
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more
7/3/2023
/ Clinical Trials ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Foods ,
Medical Research ,
Pharmaceutical Industry ,
Plant Based Products ,
Popular ,
Prescription Drugs
On October 14, 2022, President Joe Biden signed Executive Order 14036, directing the Department of Health and Human Services (“HHS”) to consider innovative actions to drive down certain single-source prescription drug costs...more
DEA waivers regarding the Ryan Haight Act could play a major role in telehealth’s future.
In the first decade of the 21st century, deaths attributable to overdoses of prescription drugs saw an alarming spike in volume,...more