|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA publishes draft guidance on electronic submission of expedited safety reports On August 2, 2022, FDA published a draft guidance for industry, "Electronic Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies." This guidance provides instructions for the electronic submission of serious adverse events (SAEs) in expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies through the FDA Adverse Event Reporting System (FAERS). ICSRs in FAERS include critical information FDA uses during ongoing safety surveillance across the drug life cycle. Submitting ICSRs from IND-exempt BA/BE studies electronically is voluntary. In the past, SAEs from IND-exempt BA/BE studies have been reported directly to FDA's Office of Generic Drugs by email, telephone, or fax using Form FDA 3500A. Enhancements to FAERS will allow electronic submission of SAEs from IND-exempt BA/BE studies. This guidance includes recommendations for submitting an SAE in the ICSR to FAERS as an alternate avenue. There will be two options for electronic submission of ICSRs and ICSR attachments to FAERS: - FAERS database-to-database transmission direct submission through the Electronic Submissions Gateway
- Submission through the Safety Reporting Portal
Please note, FDA is not currently accepting the submission of premarket ICSRs in the E2B(R3) format. This guidance should help generic sponsors who are opting to submit electronic IND-exempt BA/BE safety reports prepare their systems. Please continue to submit IND-exempt BA/BE safety reports to the OGD mailbox and visit the FDA Adverse Event Reporting System (FAERS) Electronic Submissions website for updates. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
No comments:
Post a Comment