The FDA released its regenerative medicine policy guidelines Nov. 16.
Here are five things to know:
1. The new framework encompasses four guidance documents, offering a clearer picture of regulated biologic products.
2. Two of the documents recommend a science-based process to guarantee the safety and efficacy of the therapies while not hindering development.
3. The guidance document suite also outlines how the FDA will react to products with potential safety concerns.
4. In a press release, FDA Commissioner Scott Gottlieb, MD, said: "With the policy framework the FDA is announcing today, we're adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA's authorities and enforcement priorities."
5. The following outlines the content of the guidance documents:
• First final guidance document: clarifies which cell- and tissue-based products would qualify under the regulations if removed and implanted into the same person
• Second final guidance document: explains how the FDA interprets existing regulatory definitions, "minimal manipulation" and "homologous use"
• First draft guidance: defines how the FDA will streamline regulatory requirements for devices "used in the recovery, isolation and delivery of regenerative medicine advanced therapies"
• Second draft guidance: regards the expedited programs available to regenerative medicine therapy sponsors
"We're at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine," said Dr. Gottlieb.