Electronic Adverse Event Filing Could Be Phased In Over Four Years - FDA
Executive Summary
FDA is suggesting a four-year phase-in for mandatory electronic submissions to its adverse event reporting system in an advanced notice of proposed rule-making (ANPR) published in the Nov. 5 Federal Register.
You may also be interested in...
Adverse Event Reports Should Be 80% Electronic By Year End, FDA Hopes
FDA hopes to receive 80% of adverse event reports in electronic format by the end of the year, CDER Division of Drug Risk Evaluation Associate Director Min Chen said
Adverse Event Reports Should Be 80% Electronic By Year End, FDA Hopes
FDA hopes to receive 80% of adverse event reports in electronic format by the end of the year, CDER Division of Drug Risk Evaluation Associate Director Min Chen said
Electronic NDAs: Reviewer, Industry Training Is Focus For CDER Office
CDER's Office of Information Management will include a focus on training reviewers in the use of electronic submissions