Top Concern for CBER is Marketing of Unapproved Biologics, Says FDA Official

September 25, 2023

Companies selling unapproved biologics products is a major ongoing concern for the FDA’s CBER, says an agency consumer safety expert, speaking at the 2023 PDA/FDA Joint Regulatory Conference on Wednesday.

Biological drug products must have an approved biologics license application or be investigated under an approved investigational new drug application, emphasized Daniel DeCiero, a consumer safety officer in the FDA’s Office of Compliance and Biologics Quality (OCBQ), noting that CBER has sent four warning letters and six untitled letters to firms over the past year.

And DeCiero divulged that current Good Manufacturing Practices (cGMP) violations are occurring at multiple unapproved human cell, tissue, and cellular and tissue-based product (HCT/P) manufacturers, with several deficiencies rising to be top concerns for the agency.

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