Covid Drug and Biological Product Development Guidance

FDA has issued an immediately-in-effect guidance, Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, to assist sponsors in the clinical development of drugs for treating or preventing Covid-19. The document does not apply to preventive vaccines and convalescent plasma.

The guidance describes the agency’s current recommendations for Phase 2 and Phase 3 trials for drugs under development to treat or prevent Covid-19. The recommendations focus on the population, trial design, efficacy endpoints, safety considerations, and statistical considerations for the clinical trials.

The guidance addresses considerations for the treatment or prevention of acute Covid-19 and does not address drug development programs targeting the treatment of persistent or late symptoms after recovery from acute illness.

The guidance will remain in force until the end of the HHS pandemic public health emergency.