| On February 22, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance titled "COVID-19: Developing Drugs and Biological Products for Treatment or Prevention." This guidance describes FDA's current recommendations regarding phase 2 or phase 3 trials for drugs or biological products under development for the treatment or prevention of COVID-19. These recommendations focus on the population, trial design, efficacy endpoints, safety considerations, and statistical considerations for such clinical trials. The guidance addresses considerations for the treatment or prevention of acute COVID-19. It does not address drug development programs targeting the treatment of persistent or late symptoms after recovery from acute illness. This final guidance revises and replaces the final guidance of the same name issued on May 11, 2020. Revisions were made to address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants and the availability of COVID-19 vaccines, in addition to the updated recommendations on patient population, trial design, efficacy endpoints, safety considerations, and statistical considerations. FDA considered comments received on the previous guidance, and editorial changes were made to improve clarity. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. This guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). However, the recommendations and processes described in the guidance are expected to assist the Agency more broadly in its continued efforts to assist sponsors in the clinical development of drugs for the treatment of COVID-19 beyond the termination of the COVID-19 public health emergency and reflect the Agency's current thinking on this issue. Therefore, within 60 days following the termination of the public health emergency, FDA intends to revise and replace this guidance with any appropriate changes based on comments received on this guidance and the Agency's experience with implementation. The final guidance "COVID-19: Developing Drugs and Biological Products for Treatment or Prevention" is available at https://go.usa.gov/xHH2t. Please refer to this guidance for more details. Sponsors engaged in developing drugs for the treatment or prevention of COVID-19 should also refer to FDA's COVID-19 web page at https://go.usa.gov/xHHTr for additional guidance documents. |
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