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
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
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
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
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more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