2/26付で米国FDAが「Electronic Submissions Presentations」と題して、電子申請関連のプレゼンテーション資料の公開ウェブサイトを更新通知しています。
下記ウェブサイトです。
興味のある方は下記URLsの各資料をご覧ください。
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm229642.htm
なお、今般の更新掲載は以下の3点の資料と思われます。
● DIA Regulatory Submissions, Information, and Document Management Forum
February 8-10, 2016, North Bethesda, MD
・ 【PDF】Electronic Submissions Update, Ginny Hussong, Director, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
・ 【PDF】eCTD Validation Update, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
● FDA/CDER Small Business and Industry Assistance (CDER SBIA) New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know
February 4, 2016
・ 【Adobe Connect：音声が再生されます】New Requirement for Electronic Submission of DMFs, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDERdisclaimer icon
下記ウェブサイトです。
興味のある方は下記URLsの各資料をご覧ください。
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm229642.htm
なお、今般の更新掲載は以下の3点の資料と思われます。
● DIA Regulatory Submissions, Information, and Document Management Forum
February 8-10, 2016, North Bethesda, MD
・ 【PDF】Electronic Submissions Update, Ginny Hussong, Director, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
・ 【PDF】eCTD Validation Update, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
● FDA/CDER Small Business and Industry Assistance (CDER SBIA) New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know
February 4, 2016
・ 【Adobe Connect：音声が再生されます】New Requirement for Electronic Submission of DMFs, Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDERdisclaimer icon
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント