Regulatory Policy Information

1/6/2025Final GuidanceInterim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic ActN/A1/6/2025Final GuidanceInterim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug,...

EIND Applications for Antiviral Products

Note: The following information is to be used by physicians who would like to request an Emergency IND for an antiviral product regulated by the Center for Drug Evaluation and Research (CDER)/Division of Antivirals (DAV). DAV regulates products that are being...