Published by FDA on 10-Jun-2014

This is one in a series of guidance documents intended to assist applicants making certain regulatory submissions in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or the Agency). This draft guidance revises and replaces the draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports, issued on June 12, 2008 .It provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments) and other postmarketing safety reports) for the following products:

• Drug products marketed for human use with approved new drug applications (NDAs)  and abbreviated new drug applications (ANDAs)
• Prescription drug products marketed for human use without an approved NDA or ANDA
• Biological products, other than vaccines, marketed for human use with approved biologi license applications (BLAs)
• Nonprescription (over-the-counter or OTC) human drug products marketed without an approved application

Click here to view the full draft guideline.