Medical and Regulatory Affairs

Investigational New Drug Applications: 4 Common Mistakes

Before starting Phase 1 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:

1. Underestimating the time and resources necessary to complete an IND

INDs pull together multiple disparate disciplines and demand heavy collaboration between multiple disciplines to create a clear, consistent message regarding a new drug’s safety. This process can be deceptively complex and time-consuming, especially for organizations preparing an IND for the first time.

2. Disorganized information

When writing an IND, always think about the FDA reviewers who will be evaluating the document. Including unnecessary information, disorganized data, and dense text are all too common missteps in IND submission. These errors increase the amount of time it takes to review your IND. It also makes it easier for errors to slip through the cracks, increasing the chance of rejection. Additionally, providing too much information could reveal a lack of cohesive strategy within your company — not the message you want to send to regulatory agencies.

Of course, too little information isn’t good, either. Forgetting to provide relevant explanations or supporting data for the results or failing to properly match results to the protocol are two other common traps in IND preparation.

3. A lack of editing

Many IND writers make the mistake of focusing solely on the science, forgetting to edit for grammar and formatting. Submissions that are difficult to read are more likely to be rejected or put on hold. Make your reviewer’s job easier by prioritizing readability within your text. A successful IND is one that is clear, concise, and free from errors.

4. Failure to follow FDA guidance

The FDA publishes detailed instructions for IND submissions. Be sure to familiarize yourself with all guidance documents pertaining to your IND during preparation. Don’t delay development for your drug with an unnecessary IND rejection.

Want to know more about these common mistakes, as well as how to avoid them? Be sure to read our recent white paper on the subject.