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- Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changesThe pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
- FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertisingFDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…