The U.S. Food and Drug Administration (FDA) recently released a new draft guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies. Previously, individual case safety reports (ICSRs) from IND-exempt bioavailability/bioequivalence studies have been submitted through more traditional avenues including email, phone, and fax. This guidance provides instructions on how to now electronically submit them to the FDA Adverse Event Reporting System (FAERS) as an alternate option.
What is covered in this draft guidance?
- Methods for Electronic ICSR Submission
- Identification of the ICSRs
- ICSR Attachments
- Initial and Follow-Up ICSRs
- Product Names for Study Drugs
- Description of Drug Exposure
- Notification of Receipt of Electronic ICSR Submission by the FDA
View the draft guidance for more details including additional supportive resources