Periodic Adverse Drug Experience Reports (PADERs) submit in an electronic format
FDA issued a final rule on June 10, 2014, that requires industry to submit postmarketing safety reports in an electronic format. The final rule and accompanying draft guidance, Providing Submissions in Electronic Format—Postmarketing Safety Reports, applies to virtually all postmarketing safety reports for human drug and biologic products, which includes individual case safety reports (ICSRs) and periodic safety reports.
The final rule issued with a draft guidance for industry. FDA will start accepting PADER submission in eCTD format from June 10, 2015.
