The US FDA’s Coronavirus Treatment Acceleration Program (CTAP) and Considerations for Pre-IND Meeting Requests

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The Coronavirus Treatment Acceleration Program (CTAP) has been created by the US Food and Drug Administration during the COVID-19 public health emergency. Guidance documents have been created to facilitate the development of possible therapies and provide streamlined processes for feedback during this pandemic. It is recommended that sponsors seek initial advice under a Pre-Investigational New Drug (pre-IND) meeting request for investigational uses of unapproved drugs as well as for new indications of US FDA–approved drugs; therefore, the Center for Drug Evaluation and Research (CDER) has established a COVID-19 scientific triage team to ensure the completeness and sufficiency of the information provided by sponsors for expedited review by the Agency. Discussion of what constitutes a complete package for IND review, case studies, and related challenges will be presented from a nonclinical perspective.