Replies to post #77886 on NanoViricides Inc. (NNVC)

[robi-1-kenobi]

Yes, FDA guidance for Expedited Programs for Serious Conditions may provide a path for faster FDA review and approval of the IND than EMA (and TGA).

I just looked up the guidance and it says the trial sponsor may apply for the Expedited Program designations with the IND submission. If granted, this could make the FDA review and approval faster than for EMA (and TGA).

However, just to support my original point (yes even though it is likely not relevant to NNVC - I gotta at least defend the reason for my original irrelevant point):

FDA has faster average NDA reviews in these comparisons to EMA and Health Canada, but they don't include IND review times. In addition, the rankings are based on averages. The higher distribution of data points at the upper end of the range means FDA is slowest for a large portion the of drug filings.

I have not seen similar data for IND review times.

My opinion (not proof) of possibly generally slower FDA IND review is based on own experience working with CDER/CDRH on Class III combination products. There is about a 1-3 year delay after CE mark for EU until PMA approval for US on many products. This means EU is able to use the latest medical devices about 1-3 years before they are available in the US. Much of this lag is due to stricter requirements for clinical trials in US vs. EU (IDE submission for devices is similar to IND for drugs).

So generally for IND reviews, I think FDA may be slower than EMA based on that experience.