OPDP’s Latest Reminder on Preapproval Promotion September 2, 2026 By Sarah Wicks & Dara Katcher Levy & Jeffrey N. Wasserstein —

https://www.thefdalawblog.com/2026/09/opdps-latest-reminder-on-preapproval-promotion/?utm_source=rss&utm_medium=rss&utm_campaign=opdps-latest-reminder-on-preapproval-promotion For anyone who thought FDA’s Office of Prescription Drug Promotion (OPDP) had lost interest in pre-approval promotion, think again. On August 21, 2026, OPDP issued an Untitled Letter to Alar Pharmaceuticals concerning promotional claims for ALA-3000 injection, an investigational extended-release ketamine product being developed for treatment-resistant depression (TRD) displayed at an exhibit booth at the American Psychiatric Association’s 2026 Annual Meeting earlier this year.