Earlier quoted context omitted.
To the best of your knowledge, would it be illegal (notwithstanding any copyright claims) to produce an interface that would make FDA compliance easier? Examples: - a website that republishes FDA information in a far easier to grok manner (assuming they are as impenetrable as most government websites I've had the misfortune to require using) - a choose-your-own-adventure formatted application made in Twine that would…
Good question. Broadly speaking, the whole regulatory space (not just FDA, but all other agencies) is indeed a massive business opportunity. There are basically two ways to operate here: Option 1: reduce costs of complying with FDA. Option 2: reduce the power of FDA. Option 1 means automation of form submissions, NLP/data mining on past enforcement actions, search engines for FDA.gov like FDAZilla, reproducible resea…
none of those entities have sovereign immunity!