FDA Eases Oversight of Cell, Gene Therapies to Speed Development

The FDA said it will increase flexibility in its oversight of cell and gene therapies, a move expected to help expedite the development of the complex and expensive treatments.

The agency plans to ease its regulations of the chemistry, manufacturing, and control requirements for cell and gene therapies—biologic products that are often individualized for patients and may need sophisticated manufacturing under particular time constraints.

The agency outlined flexibility for clinical development, commercial specifications, and process validation.

“Regulatory flexibility must be tailored for cell and gene therapies,” Marty Makary, commissioner of the Food and Drug Administration, said in a statement on ...