Many people working in drug development have expressed the frustrated wish that regulators would just go ahead and tell them exactly what they must do in order to move their drug through the development and approval process. The level of exasperation with the regulatory process is understandable. But the fact is, many of the questions that get routinely asked, have already been answered, by FDA and other regulatory bodies. That’s where having a guide who can show you the path through regulatory obstacles can make all the difference. I know; I’ve been there, on both sides of the table, for many years at FDA, more in industry and now, several years as a consultant.

I can work with you to identify gaps in your data that could derail your submission with FDA. What’s more, I know how to set up meetings with the Agency and, and this is all-important, get useful, actionable answers from regulators.
Here is the path that I would recommend:

1. Check to see if FDA has published a guidance on the medical condition or topic that you have questions on. Knowing what endpoints the Agency expects to see in a clinical trial is of enormous value.
2. Take a careful look at available guidance on what to include in IND submissions, whether the initial Phase 1 study or amendments to allow for Phase 2 or Phase 3 clinical trials.
3. Seriously consider meeting with FDA to raise questions about your planned approaches in the areas of clinical trial design, chemistry, manufacturing, and controls, and pre-clinical animal studies.

I can help with all three action steps above and much more. Let’s talk and see if I can help you
get your drug to patients.