ToxIC Joins Distinguished Universities and Research Institutes in Receiving FDA’s BAA Contract

On October 25, 2023 the FDA publicly announced the awardees of their Broad Agency Announcement (BAA) funding program. Among the 40 projects funded, ACMT/ToxIC’s “Real-world Examination of Naloxone for Drug Overdose Reversal (RENDOR)” project ranked second highest in funding amount, behind MIT and ahead of Stanford University. The BAA program provides the FDA with opportunities to “solicit innovative ideas and approaches to developing and evaluating FDA-regulated products by tapping into external knowledge and infrastructure in areas where FDA has limited expertise or capacities.” The RENDOR project, will initiate collection of real world data (dosing, efficacy, and side effects) on bystander and non-medical first responder administration of naloxone (and nalmefene) in San Francisco, Portland Oregon, Detroit and Pittsburgh over 4 years, beginning in March 2024.