Innovative Reformulation of a Complex, High-Drug-Load, Modified Release Dosage Form with Reduced Dosing Frequency
The FDA wants you to reformulate your opioid oral controlled-release product to provide a level of abuse deterrence. A lengthy, expensive ordeal seems inevitable. But what if you could limit and position the formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance? We helped a client in exactly this position accomplish a complex reformulation and successful CMC supplement filing in less than a year. Learn more by downloading this case study.