A purpose of this guidance is to clarify how FDA’s policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) (57 FR 22984, May 29, 1992) applies to foods derived from new plant varieties produced using genome editing.
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment