The Vitals

FDA Issues Final Guidance On HCT/P Deviation, Adds New Examples

September 08, 2017
FDA Wednesday (Sept. 6) finalized guidance outlining when manufacturers of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps) must report when infectious disease testing or donor eligibility determinations are not conducted properly. The final guidance adds more examples and recommendations for manufacturers, appearing to answer requests from industry for additional clarity. FDA said that the included examples reflect the most frequently reported HCT/P deviations, but noted that the examples are not all-inclusive and encouraged continued communication to ensure...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, news from FDA and much more.