Investigation of quality review issues and the association with application characteristics for new drug applications in first-cycle reviews

Publication date: Available online 22 August 2019Source: Regulatory Toxicology and PharmacologyAuthor(s): Jhih-Siang Liou, Lin-Chau ChangAbstractQuality, essential in the drug development and approval process, was demonstrated to be a major reason leading to multiple reviews for New Drug Applications (NDAs) submitted to the United States Food and Drug Administration (USFDA). The present study aimed at systematically investigating quality deficiencies described in the first-cycle NDA reviews of the approved drug products to identify the types of concerns and the association between the occurrence of quality deficiencies and the characteristics of the NDAs. Publicly available review documents of NDAs approved by the USFDA between January 1, 2009 and August 31, 2018 were retrieved from the Drugs@FDA database. Issues frequently observed included those related to pharmaceutical development, control of drug product, stability of drug product, and facility/Good Manufacturing Practice. NDAs involving more resources and higher priority, such as new molecular entities, NDAs submitted under section 505(b) (1) of the Federal Food, Drug, and Cosmetic Act, with priority review status, granted ‘accelerated approval’, with Investigational New Drug applications, with end-of-phase 2 meeting(s), were found to be associated with lower frequencies of quality deficiencies. Increased attention to quality aspects would be highly recommended to ensure the safe and efficacious use of drugs and to ...
Source: Regulatory Toxicology and Pharmacology - Category: Toxicology Source Type: research