As the COVID-19 pandemic evolves across the globe, the search for effective therapies also continues to gain momentum, including the possibility of repurposing existing medications that may show effectiveness against COVID-19 symptoms.
Join us for an expert discussion and critical insight regarding the 505(b)(2) application process in the U.S.A., for approving existing medications or combinations for use in new treatment areas such as COVID-19. Important considerations for program development, including safety and efficacy parameters, timelines, and approaches are presented.
In this podcast we also review the availability of the latest guidelines and the flexible and changing conditions around clinical trial management during this time. Over 40 documents have been published by the FDA in this regard, to help sponsors and providers move more quickly. Also discussed are guidances and programs, such as the Coronavirus Treatment Acceleration Program (CTAP), compassionate treatment programs, and EMEA and other international regulatory frameworks.
Listen to the podcast here:
or see the video version on our YouTube channel
Keep up to date with the constantly changing environment. As new information comes to light, the following websites may be useful in tracking the most recent communications:
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.