Cell Therapy Enforcement Discretion Ending, But US FDA Still Faces Challenge Going After Bad Actors
Planned 31 May revocation of enforcement discretion for certain cell therapy products without IND or BLA is important, but experts say the FDA’s next moves are what will really shape the field and patient safety moving forward.
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Pew Charitable Trusts calls for FDA to take more aggressive enforcement against regenerative medicine products, but the outcome of a bench trial involving two stem cell clinics may limit what the agency can do.
Entities that already have received letters from the agency raising concerns about marketing unapproved products may not necessarily be the first to face enforcement actions, CBER official says.
US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period.