In April I presented a webinar under the auspices of the DIA concerning preclinical bridging. During this webinar, we discussed the need to fill the toxicology gaps that may have been created during the time since the original reference listed drug was approved. These gaps, I stated, has led to the unfounded belief that the Sponsor must actually conduct these studies. I posted an example where a full tox package was developed(!).
I presented sources of toxicology information that might serve in lieu of a Sponsored study. But I also stressed that even this might not be needed. The PIND meeting is a great place to find out. Mutual Pharma evidently thought they needed to conduct an in vivo and in vitro study for their Fibricor(R) product. They requested FDA’s concurrence that the studies were suitable – they should have asked if they were needed, but FDA bailed them out and told them ‘nice to have , but not needed’.
One thing you should learn from these two postings – don’t move ahead with toxicology studies before you have consulted experts in the 505(b)(2) field and/or have had a PIND meeting that contains all of the right questions.