This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.New chapters cover: ULLIthe marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance/LILIpharmacovigilance programs designed to prevent widespread safety issues/LILIlegal issues surrounding the sourcing of foreign APIs/LILIthe issues of counterfeit drugs/LILIupdates on quality standards/LI/UL
具體描述
讀後感
用戶評價
相關圖書
本站所有內容均為互聯網搜索引擎提供的公開搜索信息，本站不存儲任何數據與內容，任何內容與數據均與本站無關，如有需要請聯繫相關搜索引擎包括但不限於百度，google,bing,sogou 等
© 2025 onlinetoolsland.com All Rights Reserved. 本本书屋 版权所有