Regulatory Alert: FDA Releases HCT/P Guidance Documents
FDA released four draft and two final tissue guidances on January 6, 2025, for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). EBAA will be hard at […]
DRAI Alert
Release of Updated Uniform DRAI Forms A fully updated Birth Mother Uniform Donor Risk Assessment Interview (DRAI) has been released for use when the donor is less than 18 months […]
Regulatory Alert: FDA Releases Information About Oropouche Virus and HCT/P Donation
On November 1, 2024, FDA published a Safety and Availability Communication, titled “Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding the Oropouche Virus and […]
REGULATORY ALERT: FDA’s Determination that Zika Virus is No Longer a RCDAD
Withdrawal of Guidance titled “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products” FDA regulations require HCT/P establishments […]
Regulatory Alert: FDA Inspectional Focus on Donor Eligibility With Regard to Sepsis
BACKGROUND Several recent FDA inspections of eye banks have resulted in Form FDA 483, Inspectional Observations, for not determining donors to be ineligible with a diagnosis of sepsis. All cited […]
