I am very interested in improving approval times, approval costs, and accelerating as much as possible and improving the current situation.

But having done one filing and read tons of filings and talking to others, I don't have many complaints with the current setup.

The closest I have to a complaint is the attitude of a single person who served on an approval committee who wrote advice to those making applications, and that person seemed to have little acceptance of their own role in the process, specifically the high cost of saying "no" unnecessarily.

As with any approval body, their decisions have huge penalty for incorrectly saying "yes" but zero penalty for incorrectly saying "no". But the FDA, of all the approval bodies I have dealt with, such as IRBs, has managed the best in my experience.

My experience may not be representative though.

Edit: thinking again, I do have one request, pandemic related. I think the FDA should rely more heavily on artificial standards for evaluating diagnostic tests for infectious agents. A key bottleneck in Covid19 diagnostics was obtaining clinical samples to validate new tests, and allowing more validation is synthetic samples would have greatly expanded testing capacity more quickly.