505(b)(2) Regulatory Pathway: What Are The Advantages And Does Your Product Qualify?

Under the Food, Drug, and Cosmetic Act, there are three regulatory pathways for drugs to gain marketing approval in the United States:

• 505(b)(1) New Drug Application (NDA): An application for a new drug with a novel active ingredient, with the requirement to provide complete information to support the drug’s efficacy and safety, derived from studies for which the applicant has right of reference
• 505(b)(2) NDA Pathway: An application for a new drug product that includes one or more studies (clinical or nonclinical) that are necessary for approval but were not conducted by the applicant and for which the applicant does not have right of reference
• 505(j) Abbreviated NDA: An application for a drug that is a generic equivalent of a previously approved drug, relying upon data demonstrating bioequivalence to a previously approved “reference listed drug”

Over the past two decades, the development of drug products that fall somewhere “between” a brand new drug with a novel active ingredient and a pharmaceutically-equivalent generic drug (in other words, drugs that could qualify for a 505(b)(2) pathway) has grown extensively. This growth is due to the advantages offered by the 505(b)(2) pathway for more expeditious development of a new product, as well as the breadth of products that may qualify for this pathway.