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Abstract
The Food and Drug Administration oversees the regulation of drugs, biologics, medical devices, and Section 361 human cell, cellular and tissue-based products (HCT/Ps), a product classification regulated by Section 361 of the Public Health Service Act. FDA applies different mandatory safety event reporting requirements from manufacturers for HCT/P (adverse reaction reporting) s than non-HCT/P products (adverse event reporting). This prospective study reviews and compares reporting, and other regulatory considerations and requirements, of HCT/Ps and non-HCT/Ps and compares available data to identify safety gaps in mandatory reporting and the FDA’s oversight of product safety. Potential gaps are identified regarding the reporting framework of HCT/Ps, the FDA’s HCT/P oversight strategy, and the FDA’s ability to inform and protect the general public health; the study is recommended for repetition to achieve statistical significance.