Cell Therapies: US FDA Asked To Clarify Development Standards For Early-Phase Trials
Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry.
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Mesenchymal stem cells have encouraging early data in ARDS, but the stem cell industry’s shady reputation complicates perception – and trial enrollment.
FDA Signals Willingness To Grant Regulatory Flexibility For Cell and Gene Therapy Products In CMC Reviews
US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.
CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.