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22 May 2013
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As any regulatory professional can attest, finding information on the US Food and Drug Administration's (FDA) website is difficult—really, really difficult, even.So difficult, in fact, that it has
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22 May 2013
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The US Food and Drug Administration (FDA) has released a new manual of policies and procedures (MAPP) for its internal drug regulatory staff regarding the creation and maintenance of its electronic
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22 May 2013
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More than a few Warning Letters sent by the US Food and Drug Administration (FDA) over the years have referenced products that tried to skirt regulation by presenting themselves to regulators as a
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22 May 2013
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US regulators regularly send letters to industry regarding alleged transgressions, deficiencies and faults. The most common ones are well-known to the industry: Form 483s outline deficiencies found
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22 May 2013
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Emails sent by drug regulators working for the US Food and Drug Administration (FDA) are about to get a bit more standardized and a bit less annoying, according to a new internal staff policy posted
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22 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US Accuracy of Blood Glucose Meters Draws FDA Scrutiny (KHN) (Medical Daily) Law Firm: FDA's
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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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