COVID-19 was declared a global pandemic on March 11, 2020. As the novel coronavirus continues to dominate headlines and impact communities around the globe, many life-sciences and pharmaceutical companies are working hard to develop tests, treatments, and vaccines to combat the virus. To help steer these companies in the right direction, the United States Food and Drug Administration (FDA) has developed and issued several rulings and guidances regarding SARS-CoV-2 and COVID-19. To keep our partners and other industry professionals up to date on the latest news, we have been adding links to these FDA guidance documents to the QPS website.
According to the FDA, the agency is “committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid coronavirus disease 2019 (COVID-19) response efforts.” The FDA’s process for publishing COVID-19 related documents complies with their good guidance practices and allows the agency to publish items quickly. When it is not feasible or appropriate to do so, the FDA is not seeking out public comments prior to publication. However, all guidances remain subject to comment and the FDA will revise its documents when necessary.
Let’s take a look at a few of the communications and guidance documents issued:
- Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts: This statement explains the FDA’s thoughts on serological tests, including expanding access to accurate and reliable serology tests and protecting Americans from fraudulent tests.
- Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers: This resource for healthcare providers discusses information regarding serological (antibody) tests. While it recommends serological tests in hospitals, it also recognizes the limitations of these tests.
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): This guidance document is designed to help labs and commercial manufacturers accelerate the availability of COVID-19 tests during this public health emergency.
- FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency: This guidance document reflects on how clinical trials might proceed during the pandemic. For example, it discusses changes such as using alternate laboratories or imaging centers and video conferencing with trial participants. It also discusses alterations to ongoing trials.
- COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products: This guidance document recommends a process designed to increase efficiency for drug and biological product developers seeking feedback on their supporting data, in the hope that these developers will be able to start clinical trials for their COVID-19-related drugs as soon as possible. It also clarifies the type of data that sponsors must provide before submitting an application to initiate studies.
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: This guidance document offers recommendations for later-stage clinical trials and summarizes critical sponsor considerations, with the goal of increasing the safety and effectiveness of COVID-19 products.
“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,” said FDA Commissioner Stephen Hahn. “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.”
QPS will continue posting links to these helpful guidances for your convenience. For links to all of these FDA guidance documents, please visit QPS’s Guidance Documents page. This page also contains guidance documents related to a variety of important topics – biomarkers, drug development, drug interaction, drug metabolites, elemental impurities, generics, labeling, method validation, product quality assessments, toxicokinetics, and more – issued by the FDA and other global regulatory agencies.
Are you looking for a CRO to assist with your preclinical or clinical drug development related to the novel coronavirus or COVID-19? QPS has CLIA-certified and GLP-compliant laboratories ready to fast-track your novel coronavirus and COVID-19 RT-qPCR/QPCR and Serological Assays and vaccine development programs. Since 1995, QPS has provided discovery, preclinical, and clinical drug development services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction, and turnkey laboratories and facilities. For more information, visit www.qps.com/coronavirus or email [email protected].