Biologics

CBER FY 2018 Product Deviation Reports

A CBER FY 2018 annual summary of biological product and HCT/P (human cells, tissues, and cellular and tissue-based products) deviations reports gives an overview of the types of reports received during the fiscal year, with detailed information about the number and type of deviations reports received. “Each firm responsible for reporting biological product and HCT/P deviations should use this information in evaluating their own deviation management program,” the Center says in the report.

During FY 2018, it says, CBER’s Office of Compliance and Biologics Quality/Division of Inspections and Surveillance entered 46,967 deviation reports into the Center’s database. It says there was a 10.1% decrease in the number of reports received in FY 2018 compared to FY 2017. However, the total number of reporting establishments increased from 2,003 in FY 17 to 2,105 in FY 18.

Compared to FY 17, there were 86 more blood and source plasma establishments, 13 more manufacturers of licensed biological products other than blood and blood components, and three more HCT/P manufacturers reporting in FY 18.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome