Guidance aligns with similar COVID-19 pandemic recommendations for sponsors of human drugs, biologics and medical devices released in March.

April 3, 2020

1 Min Read
FDA building.jpg

The U.S. Food & Drug Administration issued a statement that the agency "is aware that the COVID-19 pandemic may have an impact on ongoing studies being conducted to support new animal drug development."

Therefore, to help minimize the potential impact of the COVID-19 pandemic on new animal drug development, FDA has issued a guidance with recommendations for sponsors conducting ongoing studies to support new animal drug development, the statement said.

FDA said 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. The guidance also addresses questions regarding the FDA Center for Veterinary Medicine's coordination with foreign regulatory authorities during the pandemic.

According to FDA, the guidance aligns with similar recommendations released in March for sponsors of human drugs, biologics and medical devices.

FDA said this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the U.S. Department of Health & Human Services, including any renewals made by the HHS secretary in accordance with section 319(a)(2) of the Public Health Services Act.

Subscribe to Our Newsletters
Feedstuffs is the news source for animal agriculture

You May Also Like