FDA issues two guidances to accelerate Covid-19 treatments
The 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.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.