According to FDA Commissioner Stephen Hahn:
Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We are committed to maximizing our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products and believe these new guidances will help innovators and researchers do just that.
The new guidances that were revealed on Monday serve two key purposes:
- Streamlining the application submission process for new pharmaceuticals
- Outlining best practices for pharmaceutical companies to follow when designing effective drug trials
Accelerated Application Submission
The first guidance outlines the types of data researchers should include when submitting a pre-investigational new drug application (pre-IND). This includes:
- The drug name
- A description of the active ingredient’s physical, chemical, and biological characteristics
- A description of how it will be manufactured
- If the purpose is for prevention or treatment
- Mechanism of the drug
Thorough applications are vital to accelerating the approval process, giving the FDA the clinical, nonclinical, and quality information they need to consider when evaluating patient risk. As a result, the FDA is consolidating pre-IND meeting requests and package development into one step.
Moving forward, the FDA recommends that researchers submit all interactions for COVID-19 related items through IND requests, rather than a pre-EUA (Emergency Use Authorization).
Pre-IND requests can be submitted through the Electronic Submission Gateway (preferred method), NextGen Portal, or email.
Best Practices for Drug Trials
The second guidance outlines best-practices for designing drug trials that lead to safe and effective products to prevent or treat COVID-19. This includes insights for:
- Selecting appropriate patient populations
- Determining the ideal trial duration
- Considerations for evaluating drug efficacy
- Ensuring patient safety
For more information about the recommendations, visit the official FDA site.