On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
6/24/2025
/ Clinical Trials ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Priorities List (NPL) ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements
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
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On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more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