Guidance for Industry; Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations

The Parenteral Drug Association congratulates FDA for preparing a clear guideline with the content presented in a logical and helpful fashion. The document is largely well written and the content of guideline is necessary to provide clarification to manufacturers working with adipose tissue. PDA recommends adding a couple of additional clarifications which are noted in the attachment.