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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US FDA Suggests Adding Antioxidants To Drug Formulations To Mitigate Nitrosamine Risks
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.
With 'No Transparency To Drug Quality' In US, Requiring Independent Testing Needed – Valisure
“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.
US FDA Gives Industry An Extension On Nitrosamine Risk Assessments
Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.