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5 March 2013
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The US Food and Drug Administration (FDA) will continue to grant national drug code (NDC) numbers to pharmaceutical and other drug products not explicitly approved by FDA for a given indication after
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13 December 2012
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A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility.The company, Performance Products Inc (PPI), was accused of
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6 July 2012
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US regulators said they intend to take enforcement action against manufacturers of unapproved oxycodone products, saying the products constitute a “high public health priority” and have a high
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29 June 2012
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The US Food and Drug Administration (FDA) has issued a debarment order against a man convicted of introducing two pharmaceutical products into interstate commerce in violation of federal law after he
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6 June 2012
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The US Food and Drug Administration’s (FDA) latest batch of Warning Letters, released 6 June, cites three companies who are alleged to have violated current good manufacturing regulations and, in two
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6 June 2012
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Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the
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30 May 2012
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The US Food and Drug Administration’s (FDA) newest batch of warning letters was released on 29 May 2012, and some familiar faces have come under further scrutiny. Medical device manufacturer McNeil
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Regulatory Update
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11 May 2012
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Despite the recognized life extending benefits of Sanofi’s new prostate cancer drug, Jevtana (cabazitaxel), the UK's National Institute for Health and Clinical Excellence (NICE) has recommended
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29 February 2012
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Globus Medical Inc., a Pennsylvania-based medical device manufacturer, has reached an agreement with the US Food and Drug Administration (FDA) to pay a $550,000 fine for reportedly violating the
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