US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.
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Agency recommends “mitigation strategies” also including designing formulations that incorporate excipients such as sodium carbonate which modify the micro-environment to neutral or basic pH.
“I think one of the big issues of how the FDA regulatory framework works is that it's very rare that the FDA actually tests anything. It's all self-reported testing, by manufacturers that are also selling the product,” says Valisure CEO David Light.
Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.