{"title":"美国食品药品监督管理局评估的缩写新药申请中常见的化学、制造和控制缺陷:获得成本效益高的药物的障碍","authors":"Samruddhi B. Kulkarni , Vinod L. Gaikwad","doi":"10.1016/j.vascn.2023.107295","DOIUrl":null,"url":null,"abstract":"<div><p>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”.</p></div>","PeriodicalId":16767,"journal":{"name":"Journal of pharmacological and toxicological methods","volume":"123 ","pages":"Article 107295"},"PeriodicalIF":1.3000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Samruddhi B. Kulkarni , Vinod L. Gaikwad\",\"doi\":\"10.1016/j.vascn.2023.107295\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>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”.</p></div>\",\"PeriodicalId\":16767,\"journal\":{\"name\":\"Journal of pharmacological and toxicological methods\",\"volume\":\"123 \",\"pages\":\"Article 107295\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of pharmacological and toxicological methods\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1056871923000461\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of pharmacological and toxicological methods","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1056871923000461","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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
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”.
期刊介绍:
Journal of Pharmacological and Toxicological Methods publishes original articles on current methods of investigation used in pharmacology and toxicology. Pharmacology and toxicology are defined in the broadest sense, referring to actions of drugs and chemicals on all living systems. With its international editorial board and noted contributors, Journal of Pharmacological and Toxicological Methods is the leading journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists.