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.
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Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
Court denies FDA request for summary judgement in suit against two clinics treating patients with cells derived from their fat tissue; trial to determine whether exception to FDA regulation applies.
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.