The US Food and Drug Administration (FDA) on Monday evening issued two guidances intended to accelerate the development of products to treat or prevent coronavirus disease (COVID-19), laying out recommendations to help companies get to the investigational new drug application (IND) stage and clinical trial design considerations for later-stage studies.
“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. 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,” said FDA Commissioner Stephen Hahn.
The new guidance follows the launch of FDA’s coronavirus treatment acceleration program (CTAP) in March and the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) public-private partnership in April. (RELATED: New FDA program to accelerate coronavirus treatments, Regulatory Focus 31 March 2020; COVID-19: FDA, EMA and 16 drugmakers take part in development effort, Regulatory Focus 17 April 2020).
As of Monday, FDA said there are 144 active clinical trials of therapeutics for COVID-19 and that it is aware of more than 450 development programs that are still in planning stages…