FDA Adverse Event Electronic Reporting Delayed To Complete Portal Roll-Out
This article was originally published in The Pink Sheet Daily
Because some submitters will not have enough time to register for new electronic submission system, FDA will continue accepting paper post-marketing safety reports a little longer.
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Companies must submit post-market safety reports electronically beginning in June 2015; waivers will be allowed, but they would only be temporary.
FDA's proposed rule to require electronic submission of adverse event information would mandate a switch that industry already seems to be making rapidly
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.