FDA New General Instructions for Completing the Biological Product Deviation Report (BPDR) – Form FDA 3486/ Instructions for Using the eBPDR System (From Catapult’s regulatory round-up -October 2023)

These instructions are to be used by manufacturers to report biological product deviations (BPD) to the Center for Biologics Evaluation and Research (CBER) that may affect the safety, purity, or potency of a distributed product. They may also be for use by manufactures of human cells, tissue and cellular and tissue-based products (HCT/Ps) to report HCT/P deviations. The eBPDR system should not be used for submitting BPD reports to the Center for Drug Evaluation and Research.

The General Instructions for Completing the Biological Product Deviation Report (BPDR) – Form FDA 3486 can be found here, and Instructions for Using the eBPDR System here.

Published on the 6th of november 2023. Read Catapult’s entire regulatory round-up here.