The U.S. FDA has reportedly provided a new guidance for investigators and developers of therapeutics & preventive agents, as well as recommendations amid the coronavirus pandemic.
Shared on 12th May, the guidance provides a streamlined process for new biologic product and drug application submissions, including design recommendations for clinical trials that emphasize the efficacy and safety for treating the COVID-19 disease.
The 1st guidance outlines the process that has been established for developers and investigators to receive feedback from the FDA on supporting data for Investigational New Drugs (INDs). It also includes details for sponsors regarding the background information and data that should be offered with each IND. These details address the nonclinical, clinical, & quality considerations before submitting the application.
The 2nd guidance includes advice on the later stage of clinical studies, designed to assess therapy for COVID-19 as well as the safety and efficacy of the product candidates. It also outlines several considerations such as the addition of high-risk patients and appropriate patient selections in the care assessment for COVID-19. This will enable the sponsors to design a trial that includes duration consideration as well as metrics assessment relating to efficacy and safety.
This release of new guidance by FDA is used to emphasize the ACTIV (Accelerating COVID-19 Therapeutic Interventions & Vaccines) partnership, its public-private partnership with the NIH (National Institutes of Health) as well as other agencies across Europe and the U.S. to accelerate the regulation and development of COVID-19 therapy and vaccine options. The partners also aiming towards developing a collaborative framework for the prioritization of drug and vaccine, as well as leveraging the assets and coordination of regulatory processes across various participating groups to offer a rapid response to the global health crisis.
Stephen Hahn, MD, FDA commissioner, has stated that the agency prioritizes the acceleration of the investigations of COVID-19 therapy. The recent guidance will help researchers and innovators scale up the development of medical products.
Reportedly, there are more than 130 clinical trials for potential biological products and drugs being undertaken under FDA guidance.