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New FDA Guidelines for Accelerating COVID-19 Treatments

This week, the FDA released new guidelines for innovators conducting research into COVID-19 prevention and treatment options. These new guidances build on the Coronavirus Treatment Acceleration Program (CTAP), an FDA program that accelerates distribution of new treatments to patients in need.

In this post, we'll discuss:

Goals of the suggestions
Types of data to include in pre-IND applications
Considerations for designing drug trials
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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.

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