FDA Provides Guidances to Streamline COVID-19 Trial Applications

The US Food and Drug Administration (FDA) has provided new guidance with recommendations for developers and investigators working to provide preventive and therapeutic agents during the coronavirus 2019 (COVID-19) pandemic.

The guidance, shared on May 12, provide a streamlined process for new drug and biologic product application submissions, as well as recommendations for clinical trial design that emphasize safety and efficacy for treating COVID-19.

The first guidance, titled “COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products,” outlines the process established for developers to sooner receive the FDA’s feedback on supporting data for INDs.

It also provides sponsors more details on the types of data and background information that should be provided with each IND—addressing clinical, nonclinical, and quality considerations prior to an application submission.

The second guidance, titled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,” advises on later-stage clinical trials designed to assess COVID-19 therapy and product candidates’ safety and efficacy. It outlines considerations including appropriate patient selections and the addition of high complication-risk patients in COVID-19 care assessment.

It also helps sponsors design trials to include consideration to their duration and metrics of safety and efficacy assessment.

The FDA used the release of the new guidances to emphasize the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, their public-private partnership with the National Institutes of Health (NIH) and other agencies across the US and Europe to accelerate the development and regulation of COVID-19 vaccine and therapy options.

The partners also hope to develop a collaborative framework for the prioritization of vaccine and drug candidates, as well as the coordination of regulatory processes and leveraging of assets across the participating groups to provide more rapid COVID-19 response.

In a statement accompanying the new guidances, FDA commissioner Stephen Hahn, MD, said the agency’s acceleration of safe, effective therapy investigations for COVID-19 has been one of their greatest 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,” Hahn said.

As of May 12, more than 130 clinical trials for potential COVID-19 related drugs and biological products are underway with FDA oversight.