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13 May 2013
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The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device
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22 January 2013
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The US Food and Drug Administration's (FDA) Office of Combination Products (OCP) has released a new final regulation on the current good manufacturing practices (cGMPs) used in the manufacture of
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16 January 2013
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A warning letter sent to medical device manufacturer St. Jude Medical on 10 January 2013 by the US Food and Drug Administration (FDA) says that inspectors found numerous violations related to the
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12 December 2012
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The US Food and Drug Administration (FDA) has released a new medical device draft guidance intended to assist manufacturers in designing and developing devices used by a patient in their own
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6 August 2012
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The US Food and Drug Administration (FDA) is headed toward a marked change in compliance policy in the coming years as the result of rapidly surging imports of pharmaceutical, medical device and
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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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23 May 2012
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The US Food and Drug Administration (FDA) released a new batch of warning letters on 23 May, citing two pharmaceutical manufacturers and two medical device manufacturers for a series of regulatory
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25 April 2012
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A warning letter released to the public 23 April cites medical device manufacturer Ad-Tech Medical Instrument Corporation for failure to follow medical device regulations established by the US Food
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