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    FDA recalls some ER metformin for NDMA impurity

    Some extended-release formulations of the diabetes drug metformin contained levels of a nitrosamine impurity falling above the US Food and Drug Administration’s (FDA’s) acceptable intake limit, according to recent testing conducted by the agency.   Several lots of extended-release (ER) metformin tested above the acceptable limit for N-nicrosodimethalymine (NDMA), set by the FDA at 96 nanograms per day for drugs. The substance is ingested in low levels through normal di...
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    Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Draft Guidance on Recalls of Medical Devices China Food and Drug Administration (CFDA) has released draft guidance on the recall process for medical devices. The text establishes who is responsible for detecting possible defects with medical devices, the process for alerting users of a fault and the penalties CFDA will hand out to companies that fail to mee...
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    Asia Regulatory Roundup: CFDA to Punish Clinical Trial Data Fraudsters (16 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Promises to Punish Clinical Trial Fraud, Outlines Vision for Future of Drug Regulation Chinese regulators are working with the legal system to ensure clinical trial data fraud is punished in the courts. The initiative, which is a near-term priority for officials, forms part of China’s vision for the development of its drug regulatory system between now and 2020. Chi...
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    New Studies Push FDA to Expand Label for Popular Diabetes Drugs

    Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. Prior to the label change, metformin, which at least one researcher has said is "little removed from a herbal remedy of the middle ages," was stro...