Electronic Format for Submissions; Promotional Labeling and Advertising Materials for Human Prescription Drugs

This information collection supports implementation of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371k(a)). Section 745A(a) provides for the issuance of final guidance, after public notice and opportunity for comment, specifying the electronic format for submissions to the Food and Drug Administration (FDA, us or we) for drugs and biologics.

The latest form for Electronic Format for Submissions; Promotional Labeling and Advertising Materials for Human Prescription Drugs expires 2022-05-31 and can be found here.