The FDA is keeping an eye forward, already completing over 130 clinical trials and issuing dozens of Emergency Use Authorizations that apply to the coronavirus pandemic.
Earlier this month, the U.S. Food and Drug Administration (FDA) unveiled their steps to focus on not only preventing COVID-19, but treating the disease as well. The Coronavirus Treatment Acceleration Program, a brand-new initiative, is hoping to “help move new medical products to patients as soon as possible, while at the same time determine whether they are effective and if the benefits outweigh the risks.”
Working with partners in a public-private partnership around the globe, (including the National Institutes of Health), the FDA is keeping an eye forward, already completing over 130 clinical trials and issuing dozens of Emergency Use Authorizations that apply to the coronavirus pandemic.
Trying to keep up with the speed of not only the viruses’ trajectory, but needed resources, the FDA has pooled resources and formed new partnerships to create efficiency and speed in prevention and treatment. According to the FDA regarding its actions to accelerate the development of prevention and treatment options for COVID-19:
The guidances build on steps the agency has taken to streamline its review and advice process to get studies started as quickly as possible, and they incorporate information provided to individual innovators or researchers over the past several months.
Committed to assuring “the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices,” the FDA additionally issued two new guidance documents that offer deeper insight for researchers, innovators and healthcare professionals. These downloadable guides give insight to both understanding new processes in place and offering relevant resources for those looking to learn more about the FDA’s streamlined processes for developing, rolling-out and understanding new treatments available for coronavirus.
- The first guidance document, “COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products” showcases information for drug developers to better understand clinical trials and agency feedback, with a focus on patient safety.
- The second document, “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention” focuses on the FDA’s recommendations around later-stage COVID-19 clinical trials.
The FDA stated that the above documents “are supplemented by a variety of ongoing activities and broad agency guidance to support innovative study designs, including master protocols, to test multiple products and multiple populations simultaneously and get answers on safety and efficacy as quickly as possible.”