CLARIFICATION - Submission process for expedited safety reporting from generic drug bioavailability/bioequivalence studies

The purpose of this communication is to clarify the submission process for expedited serious adverse event (SAE) safety reports from premarket bioavailability/bioequivalence (BA/BE) studies conducted to support the development of an abbreviated new drug application. In December 2012, FDA issued the Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies to help sponsors and investigators implement the 2010 Final Rule on this subject [21 CFR 320.31(d)(3)]. Generic drug companies should continue to follow the recommendations in this guidance when submitting expedited premarket SAE reports from BA/BE studies intended to support approval of generic drugs. Please note: The May 5, 2018 implementation of the eCTD regulation for commercial INDs and drug master files did not affect the current submission process for expedited premarket SAE reports from BA/BE studies intended to support approval of generic drugs.  Premarket SAE reports submitted through MedWatch and FAERS will not be identified and routed to OGD for review, as the current MedWatch form and FAERS system are unable to identify and sequester premarket SAE reports submitted from non-IND BA/BE studies. What to do: Companies with premarket SAE reports from BA/BE studies conducted in the United States should submit 7-day and 15-day expedited SAE safety reports and any additional correspondence related to these reports to: OGD-PremarketSafetyReports@fda.hhs.gov For additional information:   Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies  Electronic Common Technical Document (eCTD) web page