The Food and Drug Administration (FDA) issued a proposed rule to establish a new annual reporting requirement for investigational new drug applications (INDs), known as the FDA development safety update report (DSUR).  Additional details of the proposed rule follow: The FDA asserts that the proposed FDA DSUR would require these sponsors to provide an annual report that is more comprehensive… (Slifer, December 8, 2022) #Food and Drug Administration, #Prescription Drugs