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To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. We have outlined several areas for consideration to ensure audit readiness from start-up through submission.
The US FDA’s Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy Designation, Accelerated Approval Program, Priority Review, and Fast Track Designation can reduce your product’s development and approval timelines if pursued at the optimal time and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about the timing and planning for each of these opportunities and determine what is best for your product’s development program.
Collected data from DCTs need to be integrated with other data captured during the course of a clinical trial, and data integrity must be ensured in the absence of source data verification. Two topics will be discussed: how to manage this integration and ensure confidence in the collected data.
To obtain approval for a new product via the 505(b)(2) pathway relying upon the Agency’s findings of safety and efficacy for a previously-approved drug, the applicant must explicitly identify at least one “listed drug” for which FDA has made a finding of safety and effectiveness, containing the same active ingredient as the applicant’s new product.