mdi Consultants
On May 11, 2020 the FDA released a press announcement to address new actions to help accelerate the development of prevention and treatment options for COVID-19. The FDA has provided new guidance with recommendations for innovators and researchers. These guidance documents aim to make the process of submitting applications in initiate studies for new drugs and biological products more efficient as well as outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.
The first guidance is titled, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.” A more efficient process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible is outlined within this document. The FDA is committed to assisting sponsors get potentially effective products into study quickly, while protecting the safety of patients. Clarity on the types of data and information that should be provided to address clinical, nonclinical and quality considerations before submitting application to initiate studies are also outlined.
The second guidance is titled, “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.” This document provides the FDA’s current recommendations on clinical trials performed in the later stages that are intended to establish safety and effectiveness for COVID-19 products. Critical sponsor considerations such as appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19 are outlined within this guidance. Additionally, the guidance helps sponsors to understand how to design their trials, including considerations of study duration, assessment of efficacy and monitoring for safety. The FDA anticipates this guidance will help sponsors to efficiently design studies that may lead to the review and potential approval of safe and effective drugs and biological products to address the COVID-19 public health emergency.
In addition to these guidance documents to help expedite preventative and therapeutic options, the FDA is engaged in a public-private partnership with the National Institutes of Health and others to speed the development of COVId-19 vaccine and treatment options. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, which includes other U.S. and European government partners and more than a dozen biopharmaceutical companies, will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to COVID-19 and future public health emergencies.
If your company has any questions related to your ongoing or future clinical studies and potential medical products to assist in the prevention or treatment options for COVID-19, please feel free to email mdi Consultants with your questions to [email protected] RE: Prevention/Treatment.