FDA Proposes Biologics Reporting Addendum to Assist With Recalls

February 23, 2007
BioPharm International Editors

The FDA wants to impose new electronic reporting requirements on biological product manufacturers to assist in potential product recalls.

The FDA wants to impose new electronic reporting requirements on biological product manufacturers to assist in potential product recalls. The Center for Biologics Evaluation and Research (CBER) announced on January 30 that it is developing an addendum to its current biologics reporting form to better classify potential recalls.

“The purpose of developing the addendum was to streamline the recall classification process,” said Paul Richards, an agency spokesperson. “Where possible, the information would be submitted directly to CBER by the recalling firm, instead of to the district office who would then submit the information to CBER.”

The new form would ask for information not currently required by the agency, such as product distribution patterns, methods of consignee notification, and consignees of products for further manufacture. The agency believes this reporting will take an additional 15–45 minutes to complete.

The new form would only apply to biological products regulated by CBER and would involve approximately 5% of all biological product deviation (BPD) reporting. BPDs describe any deviations from current good manufacturing practices, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of a product. Manufacturers are currently required to report to the agency within 45 days of any potential problems with their products.

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