|On January 14, 2016 CBER has published their proposed list of guidance documents for 2016.|
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2016
This list is only a proposal but it does provide some information about areas that the FDA is currently reviewing.
This list includes documents in two general area: Blood and Blood Components (6 documents) and Cellular Tissue and Gene Therapy (3 documents) There are also two proposed documents in the “Other” category (2 documents).
Most of the documents will be issued as draft guidances, but three will be final guidances. They are:
• Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Final Guidance for Industry2 (published)
• 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 for Industry
• Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Final Guidance for Industry