Common chemistry, manufacturing, and control deficiencies in abbreviated new drug applications assessed by the US Food and drug administration: Hurdle to access cost-effective medicines

Abstract

To market a generic product in the United States, it must be registered in Common Technical Document (CTD) format with the US Food and Drug Administration. The Generic Drug User Fee Act went into force in 2012, to expedite the timely review of Abbreviated New Drug Applications (ANDA) by communicating potential defects in the application to the applicant through deficiency letters at different time intervals during the review cycle. This often delays product approval since these deficiencies must be resolved before the product can be approved. In the present study, a study was performed to analyze the recurrent queries for ANDA applications in the CTD quality module from 2013 to 2020, and the probable corrective and preventive action to be taken was drafted. The most frequently occurring queries were observed in the sections titled "Description of manufacturing process and process controls", "Controls of critical steps and intermediates", "Specifications (Control of drug product)", and "Stability data".

Keywords: ANDA; CMC deficiency; CTD dossier; Product approval; USFDA.