{"title":"Regulatory Compliance in the United States: A Comprehensive Analysis of USFDA Guidelines and Implementation Strategies","authors":"Akash Sharma, Vriti Gamta, G. Luthra","doi":"10.9734/jpri/2023/v35i177389","DOIUrl":null,"url":null,"abstract":"This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, medical devices, and food and beverages in the US market. This paper discusses the regulatory framework, key requirements, challenges faced by companies, and effective implementation strategies to achieve and maintain compliance with USFDA regulations. The findings of this research provide valuable insights for businesses operating in regulated industries and contribute to the understanding of the importance of regulatory compliance in the US.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmaceutical Research International","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.9734/jpri/2023/v35i177389","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, medical devices, and food and beverages in the US market. This paper discusses the regulatory framework, key requirements, challenges faced by companies, and effective implementation strategies to achieve and maintain compliance with USFDA regulations. The findings of this research provide valuable insights for businesses operating in regulated industries and contribute to the understanding of the importance of regulatory compliance in the US.