Before starting Phase I trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval.
The three major required areas of information in an IND include:
- Animal pharmacology and toxicology studies
- Manufacturing information
- Clinical protocols and investigator information
Of course, putting this all together in a single, cohesive document is easier said than done. We’ve talked about steps for a successful IND before, but here are the most common errors we’ve seen made with IND submissions: