Trevor Klee’s Newsletter

Share this post

I passed Step 1 of the FDA's flowchart!

trevorklee.substack.com

I passed Step 1 of the FDA's flowchart!

Trevor Klee
Jan 31
4
2
Share this post

I passed Step 1 of the FDA's flowchart!

trevorklee.substack.com

Today, I got the magical news that the FDA has finally entered my company’s name into their system. Ordinarily, this would now mean that I now need to do the other 14 steps in the flowchart to submit documents.

However, fortunately, it also means that I can now hire a consultant to submit a letter of authorization that allows his company to submit on behalf of mine. He has already done that (electronically, no less).

So, assuming nothing crazy happens, I will never have to submit anything to the FDA electronically ever again. Instead, I will email pdfs to a consultant, who will charge my company $150/hr to submit these pdfs electronically. The first document he will submit will be a fee waiver request, asking the FDA to not charge my company $130k/year for the privilege of being on their radar.

Huzzah!

2
Share this post

I passed Step 1 of the FDA's flowchart!

trevorklee.substack.com
2 Comments
George Dietrich II
Writes George’s Substack
Jan 31Liked by Trevor Klee

Awesome

Expand full comment
Reply
Raphael Lex
Jan 31

Good luck 🤞

Expand full comment
Reply
TopNewCommunity

No posts

Ready for more?

© 2023 Trevor Klee
Privacy ∙ Terms ∙ Collection notice
Start WritingGet the app
Substack is the home for great writing