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Regulatory News | 08 March 2016 | By Zachary Brennan
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases.
CBER notes that examples of HCT/Ps that are subject to adverse reaction reporting and fall within the scope of this guidance, include:
Within 15 calendar days of initial receipt of information about adverse reactions that are fatal, life-threatening, result in permanent damage or necessitates medical or surgical intervention or hospitalization, FDA must be notified, according to the guidance.
Manufacturers also must submit to FDA follow-up reports within 15 calendar days of the receipt of new information or as requested by FDA.
As far as what the adverse event report investigation should include, FDA says it should evaluate pertinent information about the recipient’s adverse reaction that might be informative about possible etiologies of the adverse reaction. Pertinent information may include: “The time course, symptoms, and outcome of the reaction; The recipient’s medical and social/behavioral history (including pre-existing medical conditions and travel history); Relevant test results; and History of transfusions, infusions, transplants, implants, and transfers that may have been a source for communicable disease transmission.”
The investigation also should include the review of processing records to determine whether there were any deviations or departures from established procedures that may have resulted in contamination or cross-contamination of the HCT/P.
And FDA says the investigation should specifically include:
FDA also requests information on what environmental control and monitoring information was reviewed in the investigation of an adverse reaction, as well as storage and distribution information and tracking and labeling information.
The agency calls on industry to implement the recommendations in this guidance within the next six months.
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271
Tags: HCT/Ps, adverse event reporting, vascular graft, amniotic membrane