Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application Guidance for Industry
This foundational guidance is intended to assist applicants in determining which abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act (FD&C) is appropriate for the submission of a marketing application to the FDA. Many potential drug product developers are not familiar with the different abbreviated approval pathways for drug products under this act — the abbreviated approval pathways described in section 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively) — or the types of data and information that are permitted to support approval under those pathways.
This guidance focuses on those applications that can be submitted as ANDAs under section 505(j) of the FD&C Act, petitioned ANDAs under section 505(j)(2)(C) of the FD&C Act, or NDAs pursuant to section 505(b)(2) of the FD&C Act. This guidance does not discuss standalone NDAs.
Submission through the appropriate Abbreviated approval pathway with Regulatory Considerations for ANDAs and 505(b)(2) Applications (Duplicates, Petitioned ANDAs, Bundling) and Scientific Considerations for ANDAs and 505(b)(2) Applications (Type of Studies, Data and Information Submitted in ANDAs, Active Ingredient Sameness Evaluation, Intentional Differences Between the Proposed Drug Product and the RLD and Other Differences) is discussed in the guidance.
Additionally the procedure for requesting assistance from FDA is also discussed in the guidance.
For details please refer to the PDF provided below: