CDER 2016 Guidance Agenda

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] CDER has published its FY 2016 guidance agenda.  Included are seven guidance documents covering blood and blood products, two in an “other” category, and four on cellular, tissue, and gene therapy products.  Two of the HCT/P guidances have already been published in draft form since the beginning of FY 2016: ● Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 (draft guidance) ● Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (draft guidance). The other two, not yet published, are: ● a final guidance on 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Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 (final guidance), and ● a draft guidance on Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products. [See IPQ January 2016 Monthly Update, p. 81 for CDER’s FY 2016 guidance agenda.]
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