Coronavirus (COVID-19) Update: FDA Issues Guidance on Conduct and Review of Studies to Support New Animal Drug Development
April 3, 2020
The FDA is aware that the COVID-19 pandemic may have an impact on ongoing studies being conducted to support new animal drug development. To help minimize the potential impact of the COVID-19 pandemic on new animal drug development, the FDA has issued guidance with recommendations for sponsors conducting ongoing studies to support new animal drug development.
These recommendations are designed to help ensure the safety of animals, their owners, and study personnel; maintain compliance with good laboratory practice regulations and good clinical practices; and maintain the scientific integrity of the data during the COVID-19 pandemic. It also addresses questions regarding CVM’s coordination with foreign regulatory authorities during the pandemic.
The guidance aligns with similar recommendations for sponsors of human drugs, biologics and medical devices released in March.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.