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Complex Therapeutic System - MD with ancillary medicinal substance + systemic drug
Hello, I am quite new to this area and I appreciate your opinion on the following issue.
My company is developing an implantable medical device that incorporates an ancillary medicinal substance (drug A), in which the drug action is secondary.
Adittionaly to the device, a second drug (drug B) will be administered systemically, reason why we are considering the medical device plus the drug B as a Therapeutic System.
The drug A was approved for clinical trials (for other medical condition) but is not in the market (the clinical trials ended because it showed no efficacy). The drug B is market-approved (oral formulation) but we need a systemic formulation that is not yet developed (we are planning a partnership with a pharmaceutical company responsible for this development).
My questions are:
Can we do a combined trial with the MD and the 2 drugs, once we need to validate the complete therapeutic system?
Can the drug A be directly approved for our clinical trial, once it was approved before for other clinical trials (by FDA)?
Thank you.