What's New at CBER

What's New at CBER

This following links have been updated recently:
Guidances Related to the Regulation of Regenerative Medicine Products and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Recording Posted: 11/16/2017 Influenza Virus Vaccine for the 2017-2018 Season Updated: 11/16/2017 CBER-Regulated Products: Current Shortages Posted: 11/16/2017; Update for C1-Esterase Inhibitor (Human) Framework for the Regulation of Regenerative Medicine Products Posted: 11/16/2017 Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff (PDF - 210KB) Posted: 11/16/2017 Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception (PDF - 79KB) Updated: 11/16/17 Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry (PDF - 107KB) Posted: 11/16/2017 Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry (PDF - 131KB) Posted: 11/16/2017