The coronavirus disease (COVID-19) outbreak has been declared a pandemic. Undeniably, the country is in the midst of an emergency brought by the COVID-19 situation posing clear and present risks to the health and lives of the general public. A global search for an effective treatment and vaccine is on the race to save the lives of infected people against this emerging disease.
Prior the surge of the pandemic, the Food and Drug Administration (FDA) undertook to create a clear, simplified, and transparent regulation on the conduct of clinical trials. As thus, Administrative Order (A.O.) No. 2020-0010 otherwise known as “Regulations on the Conduct Clinical Trials for Investigational Products” was published.
In light of the current pandemic and to further align the current regulatory processes of the FDA with the policies of the Inter-Agency Task Force for the Management of Emerging Infectious Disease Resolution and the Department of Science and Technology, this Circular is hereby issued to guide researchers in navigating the regulatory landscape for COVID-19 related clinical trials.
Read more:-> FDA Circular No. 2020-029