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21 May 2013
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The US Food and Drug Administration (FDA) is reaching out to the private sector in a bid to help it improve the quality of the postmarketing surveillance data it receives regarding biologic drugs and
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21 May 2013
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The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of
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21 May 2013
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The US Food and Drug Administration (FDA) has released a copy of a warning letter sent last week to German pharmaceutical manufacturer Boehringer-Ingelheim, citing alleged manufacturing deficiencies
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21 May 2013
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US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a
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21 May 2013
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Pharmaceutical manufacturer Sandoz has announced the recall of two lots of its cancer drug methotrexate sodium after it said particulate matter was observed in vials of the drug. The recall is at
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21 May 2013
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The US Food and Drug Administration (FDA) has announced its third meeting on patient-focused drug development, this time focusing on the views of patients with lung cancer and seeking to identify
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21 May 2013
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Earlier this year, the US Food and Drug Administration (FDA) said it wanted industry's input regarding how it could establish standardized—and mandatory—labeling for medical devices, postulating that
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21 May 2013
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Pharmaceutical manufacturer Impax Laboratories has announced the formation of a new Compliance Committee it says will be focused on providing oversight for the company's regulated activities after the
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21 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US Merck Insomnia Drug Suvorexant Safer at Lower Dose, FDA Staff Says (Bloomberg) (Reuters)
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20 May 2013
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Is the right regulatory infrastructure in place in the US to accommodate a coming onslaught of pharmacogenomics data? No, it is not, and regulators need to consider a massive re-alignment of its
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