What the FDA Wishes Every Biotech Company Knew (But Often Doesn’t)

By Jenna Levenson, PhD, RN, MS

If you’re preparing to file an IND—or even thinking about it—you might want to hear what FDA reviewers are quietly saying behind closed doors.

These aren’t secrets. They’re patterns. The same issues come up again and again in early-phase drug development—and they can derail even the most promising biotech programs.

Here are 3 key pain points the FDA wishes biotech teams would understand before they hit “submit.”

1. You’re not ready for the IND—yet.

Far too many companies submit INDs without a preclinical package that truly supports a first-in-human study. Weak toxicology data. Unclear rationale for dose selection. Mismatched animal models. These gaps don’t just raise eyebrows—they trigger clinical holds. 

What to do instead:
Design GLP-compliant toxicology studies from the start. Justify your model selection and make sure your preclinical data speaks directly to human safety. 

2. You should have talked to us earlier.

The FDA is not just a gatekeeper—it’s a resource. But many companies delay engaging or come to pre-IND meetings with unfocused, overly broad questions.

What to do instead:
Use pre-IND and INTERACT meetings to align early. Come prepared with targeted, strategic questions. Show that you’re not guessing—you’re planning.

3. This isn’t review-ready

Disorganized submissions don’t just frustrate reviewers—they delay decisions. Sloppy formatting, missing sections, unclear data crosswalks... it all adds up to a bottleneck you can avoid.

What to do instead:
Follow eCTD guidelines to the letter. Use clean, consistent formatting. And bring in regulatory writing support to make sure your submission tells a clear, compliant story.

Bottom line?

The FDA wants to see you succeed—but they expect you to do your homework.
The biotech teams that win are not just scientifically innovative. They are operationally sharp, strategically aligned, and ready to speak the FDA’s language.

If you are planning a preclinical-to-IND transition, Let’s Talk.

I work with early-stage teams to avoid these pitfalls—and move from promising concept to approved protocol with clarity and confidence.