Do all promotional materials for prescription drugs have to be submitted to DDMAC?
The regulations for submitting materials apply to holders of NDAs, ANDAs, and antibiotic applications. Manufacturers of pre-1938 products and products that have declared “not new drugs” are not required to submit specimens. All products have labels and prescribing information, however, and products without approved labeling have permitted labeling. Permitted labeling indicates FDA agrees with the label or labeling and permits its use. A manufacturer of a product with permitted labeling is responsible for assuring that advertisements and promotional labeling pieces are consistent with the product labeling.
