New Drug Submissions (NDS)
Submissions for new brand-name patented drugs include scientific information about the product’s safety, efficacy and quality, its claimed therapeutic value, conditions for use and side effects, results of pre-clinical and clinical studies, production details, packaging and labeling information.
Abbreviated NDS (ANDS) for generic drugs
The ANDS submission involves submitting data that shows how the generic product performs compared with the brand-name product. It must be shown to be as safe and efficacious as the brand-name product and must meet the same quality standards as an NDS. Submission includes scientific information, production details, packaging and labeling, and comparative bioavailability studies showing how the generic drug can deliver the same amount of medicinal ingredient at the same rate as the brand-name product.
Supplemental NDS (SNDS) for already-authorized drug products
Includes changes to dosage form or strength, formulation, manufacturing method, labeling, recommended route of administration or to expand the claims or conditions of use (indications).