Industry welcomes FDA policy on cell therapies, warns of over-zealous regulation

The International Society for Cellular Therapy (ISCT) has welcomed the US FDA’s newly-released comprehensive Regenerative Medicine Policy Framework.

The ISCT, a global professional society of the cell therapy industry, says the new FDA framework “provides additional clarification on the FDA’s risk-based regulations to define drugs, devices, and/or biological products in the regenerative medicine and cell and gene therapy industries, including processes for maintaining safety and efficacy.”

The policy framework also defines future enforcement actions against unproven therapies, treatments and products that raise concerns over safety or ethics.

The FDA’s document also provides qualifications for rapid approval for gene and cell therapies which have a demonstrable therapeutic benefit.

ISCT president Catherine Bollard said: “ISCT welcomes the efforts of the FDA to provide additional regulatory clarification for all those operating in the cell therapy field.”