FDA Publishes Draft Guidance, "Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products 

The Food and Drug Administration (FDA) announced the availability of a new draft guidance, "Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products." The FDA announcement was published in the February 20, 2015, Federal Register. The text of the guidance may be found by clicking here.

The guidance is not final and is currently open for public comment. Entities involved in the manipulation of HCT/Ps should read the guidance and determine themselves the applicability of the guidance to their programs. However, AAB's interpretation of this guidance is that FDA's requirements for reporting "Adverse Reactions" with regards to reproductive tissues has not changed.

Comments on the draft guidance are due no later than April 21, 2015. If you submit comments, please copy the AAB office.

Contact the AAB office if you have any questions.