FDA Ups Pressure On Stem Cell Therapy Makers To Follow Product Approval Rules
US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period.
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Unapproved Cell/Tissue Product Enforcement Discretion Ends; How Hard Will US FDA Crack Down?
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.
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.
Stem Cells For COVID-19: Promising Platform With A ‘Dark Side’
Mesenchymal stem cells have encouraging early data in ARDS, but the stem cell industry’s shady reputation complicates perception – and trial enrollment.