In the April 22, 2016, Federal Register, FDA announced extended comment periods for the following draft guidances: (i) Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; (ii) Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; (iii) Human Cells, Tissues, and Cellular and Tissue- Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; and (iv) Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff. Comments are due September 27, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.