FDA Releases Guidance on Accessing Records Under the Bioterrorism Act

Summary

The Food and Drug Administration (FDA) has finalized a guidance document clarifying the circumstances under which it may access and copy records related to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, also known as the Bioterrorism Act, and describes the procedure for inspecting records under the Federal Food, Drug, and Cosmetic Act.