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- Industry wants more clarity on NGS for assessing gene therapy safetyThe pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. Ho…raps · 13d ago↗ source
- This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and moreWelcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This wee…raps · 13d ago↗ source
- FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturersThe FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversigh…