TETRA BIO-PHARMA INC. COMPLETES PRE-IND MEETING WITH FOOD AND DRUG ADMINISTRATION ON PPP001
PhytoPain Pharma Inc., a subsidiary of Tetra Bio Pharma Inc., (TBP.C) has completed its pre-IND meeting with the U.S. Food and Drug Administration for its PPP001 dried cannabis drug product. The meeting was held in January, 2017, with the division of anesthesia, analgesia, and addiction products (DAAAP), Center for Drug Evaluation and Research (CDER).
The FDA provided all the necessary guidance on the design of the phase I trial in healthy volunteers and the overall product development program, including quality, non-clinical and the medical device, and on marketing requirements. Dr. Guy Chamberland, MSc, PhD, chief scientific officer and regulatory affairs, commented: "We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development. Adhering to the U.S. FDA regulations is part of Tetra Bio Pharma's dedication to the commercialization of cannabis as a prescription controlled drug and the corporation's plan to seek reimbursement by insurers for patients."