On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. The guidance document applies to clinical trials that will be conducted under investigational new drug applications, including clinical trials that are not intended to support marketing applications. Notably, the use of the term “psychedelic” in the guidance document is intended to encompass “classic psychedelics” that are understood to be 5-HT2 agonists (e.g., psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g., methylenedioxymethamphetamine (MDMA)). This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.
jCyte, Inc., a biotech company dedicated to improving the lives of patients with retinal degenerative diseases, today announced the further expansion of the company’s executive management team with the appointment of John Sholar as general counsel. The full piece can be found here: https://bit.ly/3uj3qzX
A heartfelt congratulations to John from the Husch Blackwell Healthcare,…
Over the last few decades, the healthcare industry has come to recognize that research on children is necessary to determine the safest and most effective treatments for pediatric patients. Whether your institution is part of a nationally renowned research program or participates in a few pharmaceutical research studies a year, the following two issues are critical when structuring research studies that involve pediatric patients.
Continue Reading Don’t let research on ‘little’ subjects get you in big trouble