FDA: Safety Reports for BA/BE Studies Must Also be Submitted Electronically  

Safety report for serious adverse events (SAE) observed in bioequivalence/bioavailability (BA/BE) studies are submitted as FDA MedWatch Forms (FDA 3500A Form) to the FDA. Going forward, FDA requires that sponsors of BA/BE studies submit SAE reports electronically via the ESG or the Safety Reporting Portal (SRP) only. The purpose of such reporting is to make the process of reporting generic drug safety issues identified during BA/BE studies similar to the process used for other drugs. Typically, generic drugs are expected to have the same safety profile as the listed drug. The SAEs reported during BA/BE studies were traditionally reported via the MedWatch form because they are treated similar to post-market safety reports for the listed drug. However, owing to the possibility of SAEs unique to generic drugs, FDA now expects all SAEs to be treated similarly, as new SAEs related to a given drug that must be reported to the FDA within the 7- or 14-Day window. Also, these adverse events must be included in the ANDA application. A new guidance document from FDA describes the process for electronic submission of adverse event reports to the FDA which is similar to that followed for IND studies.