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- FDA policy allowing compounding of unapproved peptides raises safety and development concernsThe Department of Health and Human Services recently approved the compounding of six peptide products that have not received FDA approval. This move expands the list of bulk substances that traditi…
- FDA issues final guidance on potency assurance for cell and gene therapy manufacturersThe FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…